97-8275. Interim Rules for Health Insurance Portability for Group Health Plans  

  • [Federal Register Volume 62, Number 67 (Tuesday, April 8, 1997)]
    [Rules and Regulations]
    [Pages 16894-16976]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-8275]
    
    
    
    [[Page 16893]]
    
    _______________________________________________________________________
    
    Part II
    
    
    
    
    
    Department of the Treasury
    
    
    
    
    
    Internal Revenue Service
    
    
    
    26 CFR Part 54
    
    
    
    
    
    Department of Labor
    
    
    
    
    
    Pension and Welfare Benefits Administration
    
    
    
    29 CFR Part 2590
    
    
    
    
    
    Department of Health and Human Services
    
    
    
    
    
    Health Care Financing Administration
    
    
    
    45 CFR Subtitle A, Parts 144 and 146
    
    
    
    45 CFR Part 148
    
    
    
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    Health Insurance Portability for Group Health Plans; Interim Rules and 
    Proposed Rule
    
    Federal Register / Vol. 62, No. 67 / Tuesday, April 8, 1997 / Rules 
    and Regulations
    
    [[Page 16894]]
    
    
    
    DEPARTMENT OF THE TREASURY
    
    Internal Revenue Service
    
    26 CFR Part 54
    
    [T.D. 8716]
    RIN 1545-AV05
    
    DEPARTMENT OF LABOR
    
    Pension and Welfare Benefits Administration
    
    29 CFR Part 2590
    
    RIN 1210-AA54
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Health Care Financing Administration
    
    45 CFR Subtitle A, Parts 144 and 146
    
    RIN 0938-AI08
    
    
    Interim Rules for Health Insurance Portability for Group Health 
    Plans
    
    AGENCIES: Internal Revenue Service, Department of the Treasury; Pension 
    and Welfare Benefits Administration, Department of Labor; Health Care 
    Financing Administration, Department of Health and Human Services.
    
    ACTION: Interim rules with request for comments.
    
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    SUMMARY: This document contains interim rules governing access, 
    portability and renewability requirements for group health plans and 
    issuers of health insurance coverage offered in connection with a group 
    health plan. The rules contained in this document implement changes 
    made to certain provisions of the Internal Revenue Code of 1986 (Code), 
    the Employee Retirement Income Security Act of 1974 (ERISA), and the 
    Public Health Service Act (PHS Act) enacted as part of the Health 
    Insurance Portability and Accountability Act of 1996 (HIPAA). 
    Interested persons are invited to submit comments on the interim rules 
    for consideration by the Department of Health and Human Services, the 
    Department of Labor, and the Department of the Treasury (Departments) 
    in developing final rules. The rules contained in this document are 
    being adopted in an interim basis to accommodate statutorily 
    established time frames intended to ensure that sponsors and 
    administrators of group health plans, participants and beneficiaries, 
    States, and issuers of group health insurance coverage have timely 
    guidance concerning compliance with the recently enacted requirements 
    of HIPAA.
    
    DATES: Effective date: These interim rules are effective on June 7, 
    1997.
        Comment dates: Written comments on these interim rules are invited 
    and must be received by the Departments on or before July 7, 1997.
        Applicability dates: For group health plans maintained pursuant to 
    one or more collective bargaining agreements ratified before August 21, 
    1996, the rules (other than the certification requirements) do not 
    apply to plan years beginning before the later of July 1, 1997 or the 
    date on which the last collective bargaining agreement relating to the 
    plan terminates without regard to any extension agreed to after August 
    21, 1996.
        The rules implementing the certification provisions do not require 
    any action to be taken before June 1, 1997, although certain 
    certification requirements apply to periods of coverage and events that 
    occur after June 30, 1996. The certification requirement for events 
    that occurred on or after October 1, 1996 and before June 1, 1997 may 
    be satisfied using an optional notice described in this preamble.
        Information collection: Affected parties do not have to comply with 
    the information collection requirements in these interim rules until 
    the Departments publish in the Federal Register the control numbers 
    assigned by the Office of Management and Budget (OMB) to these 
    information collection requirements. Publication of the control numbers 
    notifies the public that OMB has approved these information collection 
    requirements under the Paperwork Reduction Act of 1995. The Departments 
    have asked for OMB clearance as soon as possible, and OMB approval is 
    anticipated by the applicable effective date.
    
    ADDRESSES: Written comments should be submitted with a signed original 
    and three copies to any of the addresses specified below. All comments 
    will be available for public inspection and copying in their entirety. 
    Interested persons are invited to submit written comments on these 
    interim rules to:
    
    Health Care Financing Administration, Department of Health and Human 
    Services, Attention: [BPD-890-IFC], P.O. Box 26688, Baltimore, Maryland 
    21207
    Pension and Welfare Benefits Administration, U.S. Department of Labor, 
    Room N-5669, 200 Constitution Avenue, NW., Washington, DC 20210. 
    Attention: Interim Portability and Renewability Rules
    CC:DOM:CORP:T:R (REG-253578-96), Room 5228, Internal Revenue Service, 
    POB 7604, Ben Franklin Station, Washington, DC 20044
    
        Alternatively, comments may be submitted electronically via the 
    Internet by selecting the ``Tax Regs'' option on the IRS Home Page, or 
    by submitting comments directly to the IRS Internet site at http://
    www.irs.ustreas.gov/tax__regs/comments.html
        In the alternative:
        Written comments for the Department of Health and Human Services 
    may be hand delivered from 8:30 a.m. to 5:00 p.m. to:
    
    Room 309-G, Hubert Humphrey Building, 200 Independence Avenue, SW., 
    Washington, DC 20201, or
    Room C5-09-26, 7500 Security Boulevard, Baltimore, Maryland 21244-1850
    
        Written comments for the Department of Labor may be hand delivered 
    from 8:15 a.m. to 4:45 p.m. to the above address for the Pension and 
    Welfare Benefits Administration, U.S. Department of Labor.
        Written comments for the Internal Revenue Service may be hand 
    delivered between the hours of 8 a.m. and 5 p.m. to:
    
    CC:DOM:CORP:T:R(REG-253578-96), Courier's Desk, Internal Revenue 
    Service, room 5228, 1111 Constitution Avenue, NW., Washington, DC.
    
        All submissions to the Department of Health and Human Services will 
    be open to public inspection as they are received, generally beginning 
    three weeks after publication, in room 309-G of the Department of 
    Health and Human Services offices at 200 Independence Avenue, SW., 
    Washington, DC, from 8:30 a.m. to 5:00 p.m. All submissions to the 
    Department of Labor will be open to public inspection at the Public 
    Documents Room, Pension and Welfare Benefits Administration, U.S. 
    Department of Labor, Room N-5638, 200 Constitution Avenue NW., 
    Washington, DC, from 8:30 a.m. to 5:30 p.m. All submissions to the 
    Internal Revenue Service will be open to public inspection and copying 
    in room 1621, 1111 Constitution Avenue, NW., Washington, DC, from 9:00 
    a.m. to 4:00 p.m.
    
    FOR FURTHER INFORMATION CONTACT: Julie Walton, Health Care Financing 
    Administration, at 410-786-1565; Mark Connor, Office of Regulations and 
    Interpretations, Pension and Welfare Benefits Administration, 
    Department of Labor, at 202-219-4377; Diane Pedulla, Plan Benefits 
    Security Division, Office of the Solicitor, Department of Labor, at 
    202-219-4377; or Russ Weinheimer, Internal Revenue Service, at 202-622-
    
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    4695. These are not toll-free numbers.
    
     Customer Service Information: Individuals interested in obtaining a 
    copy of the Department of Labor's booklet entitled ``Questions and 
    Answers: Recent Changes in Health Care Law'' may obtain a copy by 
    calling the following toll-free number 1-800-998-7542.
    
    SUPPLEMENTARY INFORMATION:
    
    A. Background
    
        The Health Insurance Portability and Accountability Act of 1996 
    (HIPAA), Pub. L. 104-191, was enacted on August 21, 1996. HIPAA amended 
    the Public Health Service Act (PHS Act), the Employee Retirement Income 
    Security Act of 1974 (ERISA), and the Internal Revenue Code of 1986 
    (Code) to provide for, among other things, improved portability and 
    continuity of health insurance coverage in the group and individual 
    insurance markets, and group health plan coverage provided in 
    connection with employment. Sections 102(c)(4), 101(g)(4), and 
    401(c)(4) of HIPAA require the Secretaries of Health and Human 
    Services, Labor, and the Treasury, each to issue regulations necessary 
    to carry out these provisions.\1\
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        \1\ In addition to the group market regulations in this 
    document, the Department of the Treasury is issuing a proposed 
    Treasury regulation that cross-references these regulations and the 
    Department of Labor is issuing an interim regulation relating to 
    certain disclosure requirements under HIPAA. Each of these 
    regulations appears separately in this issue of the Federal 
    Register.
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    B. Overview of HIPAA and the Interim Rules
    
        Area of Guidance. The access, portability, and renewability 
    provisions of HIPAA affect group health plans and health insurance 
    issuers. Group health plans are generally plans sponsored by employers 
    or employee organizations or both. These HIPAA provisions are designed 
    to improve the availability and portability of health coverage by:
         Limiting exclusions for preexisting medical conditions;
         Providing credit for prior health coverage and a process 
    for transmitting certificates and other information concerning prior 
    coverage to a new group health plan or issuer;
         Providing new rights that allow individuals to enroll for 
    health coverage when they lose other health coverage or have a new 
    dependent;
         Prohibiting discrimination in enrollment and premiums 
    against employees and their dependents based on health status;
         Guaranteeing availability of health insurance coverage for 
    small employers and renewability of health insurance coverage in both 
    the small and large group markets; and
         Preserving, through narrow preemption provisions, the 
    States' traditional role in regulating health insurance, including 
    State flexibility to provide greater protections.
        The regulations provide guidance with respect to these provisions. 
    In implementing these new rules, the regulations provide protections 
    for individuals seeking health coverage while minimizing burdens on 
    employers and insurers.
        Reducing Burdens. The regulations reduce burdens by:
         Providing for a simple model certificate that can be used 
    by plans and issuers;
         Reducing unnecessary duplication in the issuance of 
    certificates;
         Including flexible rules for dependents to receive the 
    coverage information they need;
         Allowing coverage information to be provided by telephone 
    if all parties agree;
         Relieving plans and issuers of the need to report the 
    starting date of coverage and waiting period information where a 
    certificate shows 18 months of credible coverage;
         Including a transition rule permitting plans and issuers 
    to give individuals a notice in lieu of a certificate where coverage 
    ended before June 1, 1997; and
         Providing for a model notice that may be used to satisfy 
    the transition rule and a model notice for information relating to 
    categories of benefits provided under a plan.
        Implementing Individual Protections. The regulations protect and 
    assist participants and their dependents by:
         Ensuring that individuals are notified of the length of 
    time that a preexisting condition exclusion clause in any new health 
    plan may apply to them after taking into account their prior creditable 
    coverage;
         Ensuring that individuals are notified of their rights to 
    special enrollment under a plan;
         Permitting individuals to obtain a certificate before 
    coverage under a plan ceases; and
         Creating practical ways for individuals to demonstrate 
    creditable coverage to a new plan (where the individual's prior plan 
    fails to provide the certificate).
    
    C. Overview of Coordination of Group Market Regulation Among 
    Departments
    
        The HIPAA portability provisions relating to group health plans and 
    health insurance coverage offered in connection with group health plans 
    (referred to below as the ``group market'' provisions) are set forth 
    under a new Part A of Title XXVII of the PHS Act, a new Part 7 of 
    Subtitle B of Title I of ERISA, and a new Subtitle K of the Internal 
    Revenue Code. HIPAA also added provisions governing insurance in the 
    individual market that are contained only in the PHS Act, and thus are 
    not within the regulatory jurisdiction of the Department of Labor or 
    the Department of the Treasury. (These portability provisions are 
    referred to below as the ``individual market'' provisions.)
        In general, the group market provisions create concurrent 
    jurisdiction for the Secretaries of Health and Human Services, Labor, 
    and the Treasury. The provisions include similar rules relating to 
    preexisting conditions exclusions, special enrollment rights, and 
    prohibition of discrimination against individuals based on health 
    status-related factors. (These group market provisions are referred to 
    below as the ``shared group market'' provisions.) Accordingly, the 
    three Departments share regulatory responsibility for most, but not 
    all, of the group market provisions.
        The shared group market provisions are substantially similar, 
    except as follows:
         The shared group market provisions in the PHS Act apply 
    generally to insurance issuers that offer health insurance in 
    connection with group health plans (subject to an exception that may 
    apply for plans with fewer than two participants who are current 
    employees (``very small plans'')), and certain State and local 
    government plans. Only the PHS Act contains group market provisions 
    relating to availability and renewability of health insurance.\2\ In 
    addition, the PHS Act imposes certification requirements on certain 
    federal entities not otherwise subject to the HIPAA portability 
    provisions. Further, the States, in the first instance, will enforce 
    the PHS Act with respect to issuers. In addition, individuals may be 
    able to pursue claims through State mechanisms. Only if a State does 
    not substantially enforce any provisions under its insurance laws, will 
    the Department of Health and Human Services enforce the provisions, 
    through the imposition of civil money penalties. (The group market 
    provisions relating to guaranteed renewability for multiemployer plans 
    and multiple employer welfare arrangements
    
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    (MEWAs) are in ERISA and the Internal Revenue Code, but not the PHS 
    Act.)
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        \2\ The PHS Act does not include requirements on availability of 
    insurance for employers in the large group market. Under section 
    2711(b)(3) of the PHS Act, however, the General Accounting Office 
    (GAO) is to report to Congress on such availability in 1998.
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         The ERISA shared group market provisions apply generally 
    to all group health plans other than governmental plans, church plans, 
    very small plans, and certain other plans. The shared group market 
    provisions of ERISA also apply to health insurance issuers that offer 
    health insurance in connection with such group health plans. Generally, 
    the Secretary of Labor enforces the Provisions of HIPAA that amend 
    ERISA, except that no enforcement action may be taken by the Secretary 
    against issuers relating to the new shared group market provisions in 
    part 7 of ERISA. However, individuals may generally pursue actions 
    against issuers under ERISA and, in some circumstances, under State 
    laws.
         The shared group market provisions in the Internal Revenue 
    Code generally apply to all group health plans other than governmental 
    plans and very small plans, but not to health insurance issuers. A 
    taxpayer that fails to comply with these provisions may be subject to 
    an excise tax under section 4980D of the Code. (The group market 
    provisions relating to preemption and affiliation periods for HMOs are 
    in the PHS Act and ERISA, but not in the Internal Revenue Code.)
        The regulation being issued today by the Secretaries of Health and 
    Human Services, Labor, and the Treasury have been developed on a 
    coordinated basis by the Departments. Except to the extent needed to 
    reflect the statutory differences described above, the shared group 
    market provisions in these regulations of each Department are 
    substantively identical. However, there are certain nonsubstantive 
    differences. The PHS Act regulations are numbered and organized 
    differently. Also, there are differences in the regulations that are 
    necessary because of statutory provisions that are not common to all 
    three Departments (in the definitions sections, for example). Further, 
    the regulations reflect certain stylistic differences in language and 
    structure to conform to conventions used by a particular Department. 
    These differences have been minimized and any differences in wording 
    are not intended to create any substantive difference, so that these 
    regulations will have the same effect with respect to overlapping 
    statutory provisions, as required by section 104 of HIPAA.
    
    D. Special Information Concerning State Insurance Law
    
        For purposes of the PHS Act and sections 144 through 148 in the PHS 
    Act regulations, all health insurance coverage in a State generally is 
    sold in one of two markets: the group market (See section 146) and the 
    individual market (see section 148). The group market is further 
    divided into the large group market and the small group market. Section 
    146 of the PHS Act regulations applies the group market provisions only 
    to insurance sold to group health plans (which are generally plans 
    sponsored by employers or employee organizations or both), regardless 
    of whether State law provides otherwise. State law may expand the 
    definition of the small group market to include certain coverage that, 
    under the federal law, would otherwise be considered coverage in the 
    large group market or the individual market.
        The protections provided in the PHS Act to particular individuals 
    and employers are different depending on whether the coverage involved 
    is obtained in the small group market, the large group market, or the 
    individual market. Small employers are guaranteed availability of 
    insurance coverage sold in the small group market under the PHS Act. 
    Small and large employers are guaranteed the right to renew their group 
    coverage under the PHS Act, subject to certain exceptions. Eligible 
    individuals are guaranteed availability of coverage sold in the 
    individual market under the PHS Act, and all coverage in the individual 
    market must be guaranteed renewable under the PHS Act.
        Coverage that is provided to associations, but is not related to 
    employment (so that the coverage is not in connection with a group 
    health plan), is not coverage in the group market under HIPAA. This 
    coverage is instead coverage in the individual market under the PHS 
    Act, regardless of whether it is considered group coverage under State 
    law.
    
    E. Discussion of the Shared Group Market Provisions in the 
    Regulations
    
        The most significant items relating to the shared group market in 
    these regulations are discussed in detail below.
    
    Definitions--26 CFR 54.9801-2, 29 CFR 2590.701-2, 45 CFR 144.103
    
        This section provides most of the definitions used in the 
    regulations implementing the provisions of HIPAA that were added to the 
    PHS Act, ERISA, and the Code, relating to the group market.\3\ The 
    definitions in this section of the regulations include both statutory 
    definitions provided in HIPAA, as well as certain others used in the 
    regulations.
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        \3\ The regulations for the PHS Act also contain certain 
    definitions relating to those provisions added under the PHS Act 
    regarding the individual market, in order to create a single, 
    comprehensive reference for the definitions necessary under the PHS 
    Act regulations.
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    Limitation on Preexisting Condition Exclusion Period--26 CFR 54.9801-3, 
    29 CFR 2590.71-3, 45 CFR 146.111
    
    Definition of Preexisting Condition Exclusion
        A preexisting condition exclusion is defined broadly to be any 
    limitation or exclusion of benefits based on the fact the condition was 
    present before the first day of coverage, whether or not any medical 
    advice, diagnosis, care, or treatment was recommended or received 
    before that day. HIPAA imposes certain limitations (described below) on 
    the use of such an exclusion in the group market (and also uses this 
    definition for purposes of the individual market rules, under which no 
    preexisting condition exclusion is permitted to be imposed on an 
    eligible individual). HIPAA's broad definition of a preexisting 
    condition exclusion is at variance with some State laws and regulations 
    because the relevant National Association of Insurance Commissioners 
    (NAIC) models, on which many State laws are based, have imposed 
    limitations on coverage for preexisting conditions without use of such 
    a definition.
        New Limitations on Preexisting Condition Exclusions. Paragraph (a) 
    of this section \4\ of the regulations describes the limitations on the 
    preexisting condition exclusion period. A group health plan, and a 
    health insurance issuer offering group health insurance coverage, is 
    permitted to impose a preexisting condition exclusion with respect to a 
    participant or beneficiary only if the following conditions are met:
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        \4\ References to paragraphs of a section refer to paragraphs of 
    each regulation section identified in the heading. For example, this 
    reference is to paragraph (a) in each of 45 CFR 146.111, 29 CFR 
    2590.701-3, and 26 CFR 54.9801-3.
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        1. 6-month look-back rule. The preexisting condition exclusion must 
    relate to a condition (whether physical or mental, and regardless of 
    the cause of the condition) for which medical advice, diagnosis, care, 
    or treatment was recommended or received within the 6-month period 
    ending on the enrollment date. For these purposes, genetic information 
    is not a condition.\5\ In order
    
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    to be taken into account, the medical advice, diagnosis, care, or 
    treatment must have been recommended or received from an individual 
    licensed or similarly authorized to provide such services under State 
    law and operating within the scope of practice authorized by the State 
    law. Under the new HIPAA standard, a plan would generally determine 
    that an individual has a preexisting condition through medical records 
    (such as diagnosis codes on bills, a physician's notes of a visit or 
    telephone call, pharmacy prescription records, HMO encounter data, or 
    other records indicating that medical services were actually 
    recommended or received during the 6-month look-back period). The 
    ``prudent person'' standard of some State laws (under which a condition 
    is taken into account if a prudent person would have sought care 
    whether or not care is actually received) no longer may be used to 
    determine a preexisting condition.
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        \5\ The definition of genetic information in the regulations was 
    developed taking into account hearing testimony related to genetic 
    information given in connection with Senate Report 104-156, other 
    legislative initiatives, and public comments (including those 
    submitted in response to the request for information published by 
    the Departments on December 30, 1996).
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        This 6-month ``look-back'' period is based on the 6-month 
    ``anniversary date'' of the enrollment date. As a result, an individual 
    whose enrollment date is August 1, 1998 has a 6-month look-back period 
    from February 1, 1998 through July 31, 1998.
        2. Length of preexisting condition exclusion period. The exclusion 
    period cannot extend for more than 12 months (18 months for late 
    enrollees) after the enrollment date. the 12- or 18-month ``look-
    forward'' period is also based on the anniversary date of the 
    enrollment date. A late enrollee is defined as an individual who 
    enrolls in a plan at a time other than at the first time the individual 
    is eligible to enroll or during a special enrollment period (described 
    below). If an individual loses eligibility for coverage as a result of 
    terminating employment or a general suspension of coverage under the 
    plan, then upon becoming eligible again due to resumption of employment 
    or due to resumption of plan coverage, only the most recent period of 
    eligibility is considered for purposes of determining whether the 
    individual is a late enrollee.
        3. Reduction of preexisting condition exclusion period by prior 
    coverage. In general, the preexisting condition exclusion period is 
    reduced by the individual's days of creditable coverage \6\ as of the 
    enrollment date. Creditable coverage is defined as coverage of an 
    individual from a wide range of specified sources, including group 
    health plans, health insurance coverage, Medicare, and Medicaid.
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        \6\ The phrase ``days of creditable coverage'' is used instead 
    of the statutory phrase ``aggregate periods of creditable coverage'' 
    for administrative ease in the calculation of creditable coverage. 
    Use of days of creditable coverage also conforms to the practice of 
    many States for crediting prior coverage under pre-HIPAA small group 
    market reforms.
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        Definition of Enrollment Date. The limitations on preexisting 
    condition exclusions are measured from an individual's ``enrollment 
    date.'' The enrollment date is defined as the first day of coverage or, 
    if there is a waiting period, the first day of the waiting period 
    (typically the date employment begins).
        The term ``first day of coverage'' is used in the regulations in 
    place of the term ``date of enrollment'' in the statute, such as in the 
    definitions of the terms ``preexisting condition exclusion'' and 
    ``enrollment date.'' This is intended to clarify the difference between 
    the statutory terms ``date of enrollment'' and ``enrollment date'' 
    (which have no difference in common useage).
        The term ``waiting period'' generally refers to the period in which 
    there is a delay between the first day of employment and the first day 
    of coverage under the plan. Accordingly, because the preexisting 
    condition exclusion period runs from the enrollment date, any waiting 
    period would run concurrently with any preexisting condition exclusion 
    period. Further:
         The enrollment date for a late enrollee or anyone who 
    enrolls on a special enrollment date (see the section on special 
    enrollment periods below) is the first date of coverage. Thus, the time 
    between the date a late enrollee or special enrollee first becomes 
    eligible for enrollment under the plan and the first day of coverage is 
    not treated as a waiting period.
         Because the 6-month look-back limitation runs from the 
    beginning of any applicable waiting period, the current practice of 
    some plans that require physical examinations prior to commencement of 
    coverage for the purpose of identifying preexisting conditions may be 
    affected. If the examination is conducted during the waiting period 
    (after employment begins and before enrollment), rather than before 
    employment begins, a plan may not exclude coverage for any condition 
    identified in the examination (unless, independent of the examination, 
    medical advice, diagnosis, care, or treatment was in fact recommended 
    or received for the condition during the 6-month look-back period). The 
    use of such examinations for other purposes, such as worker safety, is 
    not affected.\7\
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        \7\ However, to avoid violating the Americans with Disabilities 
    Act, Pub. L. 101-336, as amended by Pub. L. 102-166, the examination 
    should generally be conducted only after the employer has offered 
    employment to the individual.
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        Elimination of Preexisting Condition Exclusion for Pregnancy and 
    for Certain Children. A preexisting condition exclusion cannot apply to 
    pregnancy. In addition, a preexisting condition exclusion period cannot 
    be applied to a newborn, an adopted child under age 18, or a child 
    placed for adoption under age 18, if the child becomes covered within 
    30 days of birth, adoption, or placement for adoption. This exception 
    does not apply after the child has a significant break in coverage (63 
    or more consecutive days). (An example in paragraph (b)(1) of the 
    regulations illustrates these rules.)
    
    Rules Relating to Creditable Coverage--26 CFR 54.9801-4, 29 CFR 
    2590.701-4, 45 CFR 146.113
    
        As noted above, a plan or issuer that imposes a preexisting 
    condition exclusion must reduce the length of the exclusion by an 
    individual's creditable coverage. This section defines the term 
    ``creditable coverage'' and sets forth the rules for how creditable 
    coverage is applied to reduce such an exclusion period.
        Creditable coverage includes health insurance coverage and other 
    health coverage, such as coverage under group health plans (whether or 
    not provided through an issuer), Medicaid, Medicare, and public health 
    plans, as well as other types of coverage set forth in HIPAA and the 
    regulations. Comments are requested on whether the definition of a 
    public health plan should include the public health systems of other 
    countries.
        Under the definition of creditable coverage, all forms of health 
    insurance coverage are included, whether in the individual market or 
    group market, and whether the coverage is short-term, limited-duration 
    coverage or other coverage for benefits for medical care for which no 
    certificate of creditable coverage is required. Creditable coverage 
    does not include coverage consisting solely of excepted benefits as 
    defined in the regulations and described below.\8\
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        \8\ However, if an individual has coverage of excepted benefits 
    in addition to other forms of creditable coverage, coverage of 
    excepted benefits is creditable coverage. This would make a 
    difference only if a plan or issuer uses the alternative method of 
    determining creditable coverage (described below) with respect to a 
    category that includes excepted benefits. For example, coverage of 
    excepted benefits such as limited vision or limited dental benefits, 
    when offered in combination with other creditable coverage, may be 
    used to offset a preexisting condition exclusion period for a 
    category that includes those benefits under the alternative method 
    in paragraph (c).
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        Under paragraph (a)(3) of this section of the regulation, a group 
    health plan or health insurance issuer offering group
    
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    health insurance coverage may determine the amount of creditable 
    coverage of an individual for purposes of reducing the period of a 
    preexisting condition exclusion by using either the standard method 
    described in paragraph (b) or the alternative method described in 
    paragraph (c).
    Standard Method
        1. Counting. Under the standard method, the plan or issuer 
    determines the amount of an individual's creditable coverage by 
    determining all days during which the individual had one or more types 
    of creditable coverage. This determination is made without regard to 
    the specific benefits included in the coverage. If creditable coverage 
    is derived from more than one source on a particular day, all of the 
    creditable coverage that the individual had on that day is counted as 
    one day of creditable coverage.
        2. Significant break in coverage. Days of creditable coverage that 
    occur before a significant break in coverage are not required to be 
    counted by the plan or issuer in reducing a preexisting condition 
    exclusion. A significant break in coverage means a period of 63 
    consecutive days during all of which the individual did not have any 
    creditable coverage.
        a. Waiting and affiliation periods. Waiting periods and affiliation 
    periods, as defined in the regulation, are not taken into account in 
    determining a significant break in coverage. This is the case 
    regardless of whether the person ultimately fails to obtain coverage 
    under the plan (such as, where termination of employment occurs before 
    coverage begins). However, days in a waiting period or affiliation 
    period are not counted as creditable coverage.
        The regulations specify that the period between the date an 
    individual files a substantially complete application for coverage in 
    the individual market and the effective date of such coverage is a 
    waiting period, so that the period is not taken into account in 
    determining a significant break in coverage. In this way, an 
    application processing delay or omission of details on a form would not 
    cause an applicant to incur a significant break in coverage, which 
    could adversely affect an individual who seeks coverage under a group 
    health plan after purchasing coverage in the individual market.
        However, the waiting period for purchase of an individual policy 
    tolls a break in coverage only if the filing of the application for the 
    individual market insurance actually results in purchase of the 
    coverage by the individual. (See Examples 7 and 8 in paragraph 
    (b)(2)(iv)). By contrast, days in a waiting period for coverage under a 
    group health plan toll a significant break in coverage regardless of 
    whether coverage under the plan is ultimately obtained. (See Example 
    6.) The rule regarding the individual market prevents an individual 
    from avoiding a significant break in coverage by repeatedly submitting 
    applications to individual market issuers without ever purchasing 
    coverage. This rule responds to comments sent to the Departments in 
    response to the December 30, 1996 request for public comments. The 
    comments asked for clear rules on when a significant break is tolled in 
    the case of an application for individual market insurance.
        Issuers of health insurance coverage in the individual market are 
    subject to the same certification requirements that apply to plans and 
    issuers in the group market. Therefore, issuers in the individual 
    market must provide individuals with certificates that reflect 
    information regarding the beginning of the waiting period (the date of 
    application), the effective date of coverage, and the date coverage 
    ends. This will assist people with coverage in the individual market 
    who later become covered by a group health plan in demonstrating their 
    creditable coverage to the plan or issuer in the group market.
        b. Effect of State insurance law. HIPAA provides that the 
    significant break in coverage rule does not preempt State insurance 
    laws that provide longer periods than 63 days for a break in coverage. 
    (The preemption provisions are described more fully below.) 
    Accordingly, while federal law may allow a plan to disregard prior 
    coverage before a 63-day significant break in coverage, an issuer may 
    be required to take such coverage into account in order to comply with 
    State insurance law. As a result, application of the break rules can 
    vary between issuers located in different States. Similarly, the break 
    rules may vary between insured plans and self-insured plans (which are 
    not subject to State insurance laws) within a State, as well as between 
    the insured and self-insured portions of a single plan. As illustrated 
    by Example 3 in paragraph (b)(2)(iv), the laws of the State applicable 
    to the insurance policy that has the preexisting condition exclusion 
    are determinative of which break rule applies.
        Alternative Method. Under the alternative method of counting 
    creditable coverage, the plan or issuer determines the amount of an 
    individual's creditable coverage for any of five identified categories 
    of benefits. Those categories are coverage for mental health, substance 
    abuse treatment, prescription drugs, dental care, and vision care. The 
    plan or issuer may use the alternative method for any or all of the 
    categories and may apply a different preexisting condition exclusion 
    period with respect to each category (as well as to coverage not within 
    a category). The creditable coverage determined for a category of 
    benefits applies only for purposes of reducing the preexisting 
    condition exclusion period with respect to that category. The standard 
    method is used to determine an individual's creditable coverage for 
    benefits that are not within any category for which the alternative 
    method is being used. Disclosure statements concerning the plan must 
    indicate that the alternative method is being used, and this disclosure 
    must also be given to each enrollee at the time of enrollment. These 
    statements must include a description of the effect of using the 
    alternative method. Any issuer in the group market must provide similar 
    statements to each employer at the time of offer or sale of the 
    coverage.
        For purposes of reducing the preexisting condition exclusion period 
    under the alternative method, the plan or issuer determines under the 
    standard method the amount of the individual's creditable coverage that 
    can be counted, up to a total of 365 days of the most recent creditable 
    coverage of the individual (546 days for a late enrollee). The period 
    of this creditable coverage is referred to as the ``determination 
    period.'' The plan or issuer counts all days of coverage within the 
    applicable category that occurred during the determination period 
    (without regard to any significant breaks in that category of 
    coverage). Those days reduce the preexisting condition exclusion for 
    coverage within that category.
        The regulations do not provide detailed definitions of the benefit 
    categories. Comments are invited on whether additional guidance is 
    needed.
        The regulations under the alternative method of counting creditable 
    coverage do not include a category relating to significant differences 
    in deductible amounts. Commentators expressed concerns about adverse 
    selection if individuals can change from a high deductible plan when 
    they become ill and obtain ``first dollar'' coverage from an HMO or 
    other issuer that provides broad, comprehensive care with only low 
    deductibles or copayments.\9\ However, it is unclear how such a
    
    [[Page 16899]]
    
    category would be defined or applied. Accordingly, the Departments 
    solicit comments on this issue.
    ---------------------------------------------------------------------------
    
        \9\ See also the discussion below under the heading ``HMO 
    Affiliation as Alternative to Preexisting Condition Exclusion.''
    ---------------------------------------------------------------------------
    
    Certificates and Disclosure of Previous Coverage--26 CFR 54.9801-5, 29 
    CFR 2590.701-5, 45 CFR 146.115
    
        This section of the regulations sets forth guidance regarding the 
    certification requirements and other requirements concerning disclosure 
    of information relating to prior creditable coverage. The provision of 
    a certificate and other disclosures of information are intended to 
    enable an individual to establish his or her prior creditable coverage 
    for purposes of reducing any preexisting condition exclusion imposed on 
    the individual by any subsequent group health plan coverage.
        Form of Certificate. In general, the certificate must be provided 
    in writing, including any form approved by the Secretaries as a 
    writing. In certain circumstances, where the individual requests that 
    the certificate be sent to another plan or issuer instead of to the 
    individual, and the other plan or issuer agrees, the certification 
    information may be provided by other means, such as by telephone. In 
    some States, issuers transfer coverage information by telephone. 
    Comments are requested as to whether, and under what conditions, other 
    methods of transmitting certification information (including electronic 
    communication) should be permitted in future guidance.
        Information in Certificate. Paragraph (a)(3) of this section of the 
    regulations sets forth the information that must be included in a 
    certificate. The regulations allow a plan or issuer in an appropriate 
    case simply to state in the certificate that the individual has at 
    least 18 months of creditable coverage that was not interrupted by a 
    significant break in coverage and to indicate the date coverage ended. 
    (A certificate would never have to reflect coverage in excess of 18 
    months without a 63-day break because this is the maximum creditable 
    coverage that an individual could need under the preexisting condition 
    exclusion rules and the rules for access to the individual market.) In 
    any other case, the certificate must disclose (1) the date any waiting 
    or affiliation period began,\10\ (2) the date coverage began, and (3) 
    the date coverage ended (or indicate if coverage is continuing).\11\ 
    For individuals with fewer than 18 months of coverage without a 
    significant break in coverage, the information about specific dates is 
    essential in order for a subsequent plan or issuer in the group or 
    individual market to be able to apply the break rules, especially in 
    light of the possibility that an individual may have other coverage 
    from various sources and the potential differences among State break 
    rules (described above).
    ---------------------------------------------------------------------------
    
        \10\ Because the ending date for a waiting or affiliation period 
    will always be the date coverage begins, the ending date does not 
    have to be separately stated in a certificate.
        \11\ These dates would include any period of COBRA continuation 
    coverage. A COBRA continuation coverage period does not have to be 
    separately identified.
    ---------------------------------------------------------------------------
    
        Certification Events and Timing. Paragraph (a)(5) describes the 
    rights of participants and dependents to receive certificates. In 
    general, individuals have the right to receive a certificate 
    automatically (an ``automatic certificate'') when they lose coverage 
    under a plan and when they have a right to elect COBRA continuation 
    coverage. The certificate must be furnished within the time periods 
    described below:
         First, for an individual who is a qualified beneficiary 
    entitled to elect COBRA continuation coverage, the certificate is 
    required to be provided no later than when a notice is required to be 
    provided for a qualifying event under COBRA.
         Second, for an individual who loses coverage under a group 
    health plan and who is not a qualified beneficiary entitled to elect 
    COBRA continuation coverage, the certificate is required to be provided 
    within a reasonable time after the coverage ceases. (Typically, this 
    would apply to small employers' plans that are not subject to COBRA.) 
    This requirement is satisfied if the certificate is provided by the 
    time a notice is required to be provided under a State program similar 
    to COBRA.
         Third, for an individual who is a qualified beneficiary 
    and has elected COBRA continuation coverage, the certificate is 
    required to be provided within a reasonable time after either cessation 
    of COBRA continuation coverage or, if applicable, after the expiration 
    of any grace period for the payment of COBRA premiums.
    In each of these three events, the regulations require the certificate 
    to reflect only the most recent period of continuous coverage under the 
    plan.
        Under COBRA, multiemployer plans may provide notices within such 
    longer period of time as provided for such notices under the terms of 
    the plan. Under the general certification timing rule described above, 
    multiemployer plans may use the same extended time period for providing 
    certificates. Comments are requested on how this may affect a 
    multiemployer plan and its participants and their families.
        A certificate may be mailed by first class mail to the 
    participant's last known address. A certificate for a participant's 
    spouse with an address different from the participant's is to be sent 
    to the spouse's address. A certificate may provide information with 
    respect to both a participant and the participant's dependents if the 
    information is identical for each individual, or if the information is 
    not identical, a certificate may provide information sufficient to 
    satisfy the requirements of the regulations with respect to each 
    individual on one document.
        A certificate is also required to be provided upon the request of, 
    or on behalf of, an individual (whether the individual is a 
    participant, the participant's spouse, or any other dependent) if the 
    request is made within 24 months after the individual loses coverage 
    under the plan. The certificate is required to be provided at the 
    earliest time that the plan or issuer, acting in a reasonable and 
    prompt fashion, can provide the certificate. In this case, the 
    certificate reflects each period of continuous coverage ending within 
    the 24 months prior to the date of request.\12\
    ---------------------------------------------------------------------------
    
        \12\ For example, for participation who has had a number of 
    interruptions in coverage, a requested certificate could consist of 
    copies of all of the automatic certificates that were previously 
    provided to the individual for each of these periods.
    ---------------------------------------------------------------------------
    
        Responsibilities of Plans and Issuers. Paragraph (a)(1) clarifies 
    the statutory obligation of plans and issuers to provide certificates. 
    The statutory obligation to furnish a written certificate of 
    information regarding creditable coverage is imposed on both the group 
    health plan and the health insurance issuer offering group health 
    insurance coverage. This dual obligation was the subject of many of the 
    comments received by the three Departments in response to the December 
    30, 1996 request for public comments published in the Federal Register. 
    Concerns were raised about superfluous, duplicate certificates being 
    issued and the potential responsibility of issuers for reporting on an 
    individual's coverage under the plan after one issuer has been replaced 
    by another.
        Paragraph (a)(1) addresses these concerns by providing that the 
    obligation to furnish a certificate is imposed on both the plan and 
    each health insurance issuer that provides group health insurance 
    coverage under the plan, subject to four exceptions.
        First, paragraph (a)(1)(ii) provides that an entity required to 
    provide a certificate is deemed to have satisfied this requirement to 
    the extent that any other party provides the certificate and the 
    certificate discloses the creditable coverage (including the waiting 
    period
    
    [[Page 16900]]
    
    information) that was to be provided by the entity.
        Second, paragraph (a)(1)(iii) provides that a plan is deemed to 
    have satisfied its obligation if there is an agreement between an 
    issuer and a plan under which the issuer agrees to provide certificates 
    for individuals covered under the plan.
        Third, paragraph (a)(1)(iv)(A) provides that an issuer is not 
    required to provide any coverage information regarding coverage periods 
    for which it was not responsible.
        Fourth, paragraph (a)(1)(iv)(B) provides that if an individual 
    switches from one issuer to another option allowed under the plan, or 
    an issuer is replaced by another before an individual's coverage in the 
    plan ceases, the first issuer is required to provide sufficient 
    information to the plan (or to another party designated by the plan), 
    so that when the individual leaves the plan, a certificate can be 
    provided that includes the period of coverage under the policy of the 
    first issuer. In this situation, no certificate is required to be 
    provided to the individual, but the issuer must also cooperate with the 
    plan by providing any information that may be requested later pursuant 
    to the alternative method. (This rule will reduce unnecessary and 
    potentially misleading information from being received while the 
    individual's coverage under the plan is uninterrupted.) An issuer may 
    presume that it is the final issuer for an individual if the 
    individual's coverage under the policy ends at a time other than in 
    connection with the plan's open season.
        Other Entities Issuing Certificates. Paragraph (a)(6) identifies 
    the various statutory authorities that create responsibility for other 
    entities (that are not subject to a particular Department's 
    regulations) to provide certificates. As described above, there are 
    forms of creditable coverage other than coverage provided by group 
    health plans and health insurance coverage offered in connection with a 
    group health plan. Accordingly, individuals who leave coverage provided 
    by any such other entity are entitled to have that coverage counted by 
    a group health plan and may in many cases receive certificates for 
    their creditable coverage. This information is included in the 
    regulations because plans that impose a preexisting condition exclusion 
    may find it helpful to know when creditable coverage will be provable 
    through presentation of a certificate and when other forms of 
    documentation or attestation may be needed.
        In cases where certifications are provided by entities not subject 
    to ERISA's requirements, such as Medicaid, the Indian Health Service, 
    and CHAMPUS, certain adjustments in the certification rules may be 
    appropriate. The regulations do not address how the certification 
    process applies to these other programs. Comments are requested on how 
    the certification requirements may be adapted to entities responsible 
    for providing this coverage.
        Dependent Coverage Information. Dependents are entitled to a 
    written certificate of creditable coverage. Concerns were raised in 
    comments received from the public regarding the certification of 
    dependent coverage where information regarding dependents of 
    participants in plans was not available. Plans and issuers, the 
    commenters stated, often do not know the existence of dependents or 
    their coverage periods until claims are filed. To address these 
    concerns, the regulations have adopted two special rules.
        First, under a transition rule that lasts through June 30, 1998, a 
    plan or issuer may satisfy its obligation to provide a written 
    certificate regarding the coverage of a dependent of a participant by 
    providing the name of the participant covered by the plan and 
    specifying the type of coverage provided in the certificate (such as 
    family coverage or employee-plus-spouse coverage). However, if asked to 
    provide a certificate relating to a dependent, the plan must make 
    reasonable efforts to obtain and provide the name of the dependent. 
    This rule will provide plans and issuers with a transition period to 
    update their data systems to include information on dependents.
        Second, the regulations include a special rule regarding dependent 
    coverage that is not limited to the transition period. Under this rule, 
    a plan or issuer must make a reasonable effort to collect the necessary 
    information for dependents and include it on the certificate. However, 
    under this special rule, an automatic certificate is not required to be 
    issued until the plan or issuer knows (or, making reasonable efforts, 
    should know) of the dependent's cessation of coverage. This information 
    can be collected annually (during open enrollment).
        Under the transition rule and the special rule, an individual may 
    use the provisions described below to establish creditable coverage 
    (and waiting and affiliation period information).
        Information for Alternative Method of Counting Creditable Coverage. 
    Following receipt of the certificate, an entity that uses the 
    alternative method of counting creditable coverage may request that the 
    entity that issued the certificate disclose additional information in 
    order for the requesting entity to determine the individual's 
    creditable coverage with respect to any category of benefits described 
    in paragraph (b). The requested entity may charge the requesting entity 
    the reasonable cost of disclosing the information. The requesting 
    entity may ask for a copy of the summary plan description (SPD) that 
    applied to the individual's coverage or may ask for more specific 
    information. Set forth below is a model form that may be used for 
    specific coverage information about the categories of benefits:
    
    Information on Categories of Benefits
    
    1. Date of original certificate:---------------------------------------
    2. Name of group health plan
    providing the coverage:------------------------------------------------
    3. Name of participant:------------------------------------------------
    4. Identification number of participant:-------------------------------
    5. Name of individual(s) to whom this information applies: ____
    
    6. The following information applies to the coverage in the 
    certificate that was provided to the individual(s) identified above:
    
    a. Mental Health:------------------------------------------------------
    b. Substance Abuse Treatment:------------------------------------------
    c. Prescription Drugs:-------------------------------------------------
    d. Dental Care:--------------------------------------------------------
    e. Vision Care:--------------------------------------------------------
        For each category above, enter ``N/A'' if the individual had no 
    coverage within the category and either (i) enter both the date that 
    the individual's coverage within the category began and the date 
    that the individual's coverage within the category ended (or 
    indicate if continuing), or (ii) enter ``same'' on the line if the 
    beginning and ending dates for coverage within the category are the 
    same as the beginning and ending dates for the coverage in the 
    certificate.
        Demonstration of Coverage if Certificate is Not Provided. Under 
    HIPAA, in order to prevent an individual from being adversely affected 
    if the individual does not receive a certificate, the individual has a 
    right to demonstrate creditable coverage through the presentation of 
    documentation or other means. For example, an individual may not have a 
    certificate because: an entity failed to provide a certificate within 
    the required time period; an entity was not required to provide a 
    certificate; the coverage of the individual was for a period before 
    July 1, 1996; or, the individual has an urgent medical condition that 
    necessitates an immediate determination of creditable coverage by the 
    plan or issuer. Under these circumstances, an individual may present 
    evidence of creditable coverage through documents, records, third party 
    statements, or other means, including telephone calls by the plan or 
    issuer to a third party provider. The plan administrator is required to 
    take into
    
    [[Page 16901]]
    
    account all information presented in determining whether to offset any 
    or all of a preexisting condition exclusion. A plan or issuer is 
    required to treat the individual as having furnished a certificate 
    provided by a plan or issuer if the individual attests to the period of 
    creditable coverage, the individual presents relevant corroborating 
    evidence of some creditable coverage during the period, and the 
    individual cooperates with the plan's or issuer's efforts to verify the 
    individual's coverage.
        If an individual needs to demonstrate his or her status as a 
    dependent of a participant, the plan or issuer is required to treat the 
    individual as having furnished a certificate if an attestation to such 
    dependency and the period of such status is provided, and if the 
    individual cooperates with the plan's or issuer's efforts to verify the 
    dependent status.
        Similar rules apply relating to determining creditable coverage 
    under the alternative method.
        Notice to Individual of Period of Preexisting Condition Exclusion. 
    Within a reasonable time following the receipt of the certificate, 
    information relating to the alternative method, or other evidence of 
    coverage, a plan or issuer is required to make a determination 
    regarding the length of any preexisting condition exclusion period that 
    applies to the individual and notify the individual of its 
    determination. Whether a determination and notification is made within 
    a reasonable period of time depends upon the relevant facts and 
    circumstances including whether the application of the preexisting 
    condition exclusion period would prevent access to urgent medical 
    services. The plan or issuer is required to notify the individual, 
    however, only if, after considering the evidence, it has determined 
    that a preexisting condition exclusion period will still be imposed on 
    the individual. The basis of the determination, including the source 
    and substance of any information on which the plan or issuer relied, 
    must be included in the notification. The notification must also 
    explain the plan's appeals procedures and the opportunity of the 
    individual to present additional evidence.
        The plan or issuer may reconsider and modify its initial 
    determination if it determines that the individual did not have the 
    claimed creditable coverage. In this circumstance, the plan or issuer 
    must notify the individual of such reconsideration and, until a final 
    determination is made, must act in accordance with its initial 
    determination for purposes of approving medical services.
        Model Certificate. The following model certificate has been 
    authorized by the Secretary of each of the Departments. Use of the 
    model certificate will satisfy the requirements of paragraph (a)(3)(ii) 
    of the regulations.
    
    Certificate of Group Health Plan Coverage
    
        * IMPORTANT--This certificate provides evidence of your prior 
    health coverage. You may need to furnish this certificate if you 
    become eligible under a group health plan that excludes coverage for 
    certain medical conditions that you have before you enroll. This 
    certificate may need to be provided if medical advice, diagnosis, 
    care, or treatment was recommended or received for the condition 
    within the 6-month period prior to your enrollment in the new plan. 
    If you become covered under another group health plan, check with 
    the plan administrator to see if you need to provide this 
    certificate. You may also need this certificate to buy, for yourself 
    or your family, an insurance policy that does not exclude coverage 
    for medical conditions that are present before you enroll.
    
    1. Date of this certificate:-------------------------------------------
    2. Name of group health plan:------------------------------------------
    3. Name of participant:------------------------------------------------
    4. Identification number of participant:-------------------------------
    5. Name of any dependents to whom
    this certificate applies:----------------------------------------------
    6. Name, address, and telephone number of plan administrator or 
    issuer responsible for providing this certificate:
    
    ----------------------------------------------------------------------
    ----------------------------------------------------------------------
    ----------------------------------------------------------------------
    7. For further information, call:--------------------------------------
    8. If the individual(s) identified in line 3 and line 5 has at least 
    18 months of creditable coverage (disregarding periods of coverage 
    before a 63-day break), check here______ and skip lines 9 and 10.
    9. Date waiting period or affiliation period
    (if any) began:--------------------------------------------------------
    10. Date coverage began:-----------------------------------------------
    11. Date coverage ended: ______ (or check if coverage is continuing 
    as of the date of this certificate: ______).
    
        Note: Separate certificates will be furnished if information is 
    not identical for the participant and each beneficiary.
    
    Special Enrollment Periods--26 CFR 54.9801-6, 29 CFR 2590.701-6, 45 CFR 
    146.117
    
        This section of the regulations provides guidance regarding the new 
    enrollment rights provided to employees and dependents under HIPAA. A 
    group health plan and a health insurance issuer offering group health 
    insurance coverage are required to provide for special enrollment 
    periods during which individuals who previously declined coverage are 
    allowed to enroll (without having to wait until the plan's next regular 
    open enrollment period). A special enrollment period can occur if a 
    person with other health coverage loses that coverage or if a person 
    becomes a dependent through marriage, birth, adoption, or placement for 
    adoption.
        A plan must provide a description of the special enrollment rights 
    to anyone who declines coverage. The regulations provide a model of 
    such a description.
        A person who enrolls during a special enrollment period (even if 
    the period also corresponds to a regular open enrollment period) is not 
    treated as a late enrollee. (Accordingly, the plan or issuer may not 
    impose a preexisting condition exclusion period longer than 12 months 
    with respect to the person.)
        Special Enrollment for Loss of Other Coverage. The special 
    enrollment period for loss of other coverage is available to employees 
    and their dependents who meet certain requirements. The employee or 
    dependent must otherwise be eligible for coverage under the terms of 
    the plan. When the coverage was previously declined, the employee or 
    dependent must have been covered under another group health plan or 
    must have had other health insurance coverage. The plan can require 
    that, when coverage in the plan was previously declined, the employee 
    must have declared in writing that the reason was other coverage, in 
    which case the plan must at that time have provided notice of this 
    requirement and the consequences of the employee's failure to provide 
    the statement.
        The special enrollment rights may apply with respect to an 
    employee, a dependent of the employee, or both. An employee who has not 
    previously enrolled can enroll under these rules if it is the employee 
    who loses other coverage. An employee's dependent can be enrolled under 
    these rules if it is the dependent who loses other coverage and the 
    employee is already enrolled. In addition, both the employee and a 
    dependent can be enrolled together under these rules if either the 
    employee or the dependent loses other coverage.
        If the other coverage is COBRA continuation coverage, the special 
    enrollment can only be requested after exhausting COBRA continuation 
    coverage. If the other coverage is not COBRA continuation coverage, 
    special enrollment can only be requested after losing eligibility for 
    the other coverage or after cessation of employer contributions for the 
    other coverage. In each case, the employee has 30 days to request 
    special enrollment. An individual does not have to elect COBRA 
    continuation coverage or exercise similar continuation rights in order 
    to preserve the right to special enrollment. However, an individual 
    does not have a special enrollment right if the individual loses the 
    other coverage as a result of the individual's
    
    [[Page 16902]]
    
    failure to pay premiums or for cause (such as making a fraudulent 
    claim). Coverage under special enrollment must be effective no later 
    than the first day of the month after an employee request the 
    enrollment for himself or herself or on behalf of a dependent.
        Special Enrollment for New Dependents. A special enrollment period 
    also occurs if a person has a new dependent by birth, marriage, 
    adoption, or placement for adoption. The election to enroll can be made 
    within 30 days following the birth, marriage, adoption, or placement 
    for adoption. In the case of a plan that does not offer any coverage 
    for dependents and is then modified to offer dependent coverage, the 
    election to enroll can instead be made during the 30 days beginning on 
    the date dependent coverage is made available.
        The special enrollment rules allow an eligible employee to enroll 
    when he or she marries or has a new child (as a result of marriage, 
    birth, adoption, or placement for adoption). A spouse of a participant 
    can be enrolled separately at the time of marriage or when a child is 
    born, adopted or placed for adoption. The spouse can be enrolled 
    together with the employee when they marry or when a child is born, 
    adopted, or placed for adoption. A child who becomes a dependent of a 
    participant as a result of marriage, birth, adoption, or placement for 
    adoption can be enrolled when the child becomes a dependent. Similarly, 
    a child who becomes a dependent of an eligible employee as a result of 
    marriage, birth, adoption, or placement for adoption can be enrolled if 
    the employee enrolls at the same time.
        In the case of a dependent special enrollment period, HIPAA 
    provides that coverage with respect to a marriage is effective no later 
    than the first day of the month after the date the request for 
    enrollment is received and coverage with respect to a birth, adoption, 
    or placement for adoption is effective on the date of the birth, 
    adoption, or placement for adoption.
    
    HMO Affiliation Period as Alternative to Preexisting Condition 
    Exclusion--29 CFR 2590.701-7 and 45 CFR 146.119
    
        This section of the regulations permits a group health plan 
    offering health insurance through an HMO, or an HMO that offers health 
    insurance coverage in connection with a group health plan, to impose an 
    affiliation period, but only if certain other requirements are met. An 
    ``affiliation period'' is defined in the regulations as a period of 
    time that must expire before health insurance coverage provided by the 
    HMO becomes effective, and during which the HMO is not required to 
    provide benefits.
        The regulations specify the following requirements for imposing an 
    affiliation period:
         No preexisting condition exclusion may be imposed with 
    respect to coverage through the HMO;
         No premium may be charged to a participant or beneficiary 
    for the affiliation period;
         The affiliation period must be applied uniformly without 
    regard to any health status-related factors; and
         The affiliation period must begin on the enrollment date, 
    cannot exceed two months (three months for a late enrollee), and must 
    run concurrently with any waiting period under the plan.
    The regulations provide for the affiliation period to begin on the 
    enrollment date in the plan, not when coverage with the HMO begins. 
    Accordingly, if a plan offers multiple coverage options simultaneously, 
    the HMO cannot impose an affiliation period on plan participants who 
    change to the HMO option. Comments are requested on this rule.
        The regulations permit an HMO to use alternatives in lieu of an 
    affiliation period to address adverse selection, as approved by the 
    State insurance commissioner or other official designated to regulate 
    HMOs. Because an affiliation period may be imposed only if no 
    preexisting condition exclusion is used, an alternative to an 
    affiliation period may not encompass an arrangement that is in the 
    nature of such an exclusion.\13\
    ---------------------------------------------------------------------------
    
        \13\ These alternative that may be used in lieu of an 
    affiliation period to address adverse selection should not be 
    confused with the use of the alternative method for counting 
    creditable coverage discussed in the next paragraph.
    ---------------------------------------------------------------------------
    
        While HMOs usually do not impose preexisting condition exclusions, 
    they could choose to apply a preexisting condition exclusion period for 
    all enrollees based on the alternative method of counting creditable 
    coverage if the regulations were to add a category relating to 
    deductibles. However, as described above under the heading 
    ``Alternative Method,'' the regulations currently do not include such a 
    category.
    
    Nondiscrimination in Eligibility and Premiums in the Group Market--26 
    CFR 54.9802-1, 29 CFR 2590.702, 45 CFR 146.121
    
        The regulations include provisions implementing the 
    nondiscrimination provisions in HIPAA. Comments are welcomed on these 
    provisions, and, in particular, comments are requested on whether 
    guidance is needed concerning:
         The extent to which the statute prohibits discrimination 
    against individuals in eligibility for particular benefits;
         The extent to which the statute may permit benefit 
    limitations based on the source of an injury;
         The permissible standards for defining groups of similarly 
    situated individuals;
         Application of the prohibitions on discrimination between 
    groups of similarly situated individuals; and
         The permissible standards for determining bona fide 
    wellness programs.
        The Departments intend to issue further regulations on the 
    nondiscrimination rules in the near future. In no event will the period 
    for good faith compliance (specified in HIPAA sections 102(c)(5), 
    101(g)(5), and 401(c)(5)) with respect to section 2702 of the PHS Act, 
    section 702 of ERISA, and section 9802 of the Code end before the 
    additional guidance is provided.
        A plan or issuer may not establish rules for eligibility (including 
    continued eligibility) of an individual to enroll under the terms of 
    the plan based on a health status-related factor. HIPAA and the 
    regulations provide a list of health status-related factors. The 
    Departments are considering interpreting the statutory language 
    relating to eligibility to enroll so that a plan or issuer would be 
    prohibited from providing lower benefits to certain individuals based 
    on health status-related factors. Comments are welcomed on this 
    interpretation.
        Among the health status-related factors listed in the statute is 
    ``evidence of insurability (including conditions arising out of acts of 
    domestic violence).'' The Conference Report states that the inclusion 
    of evidence of insurability in the list of health status-related 
    factors ``is intended to ensure, among other things, that individuals 
    are not excluded from health care coverage due to their participation 
    in activities such as motorcycling, snowmobiling, all-terrain vehicle 
    riding, horseback riding, skiing and other similar activities.'' 
    However, HIPAA also provides that a plan or issuer is not required to 
    provide particular benefits other than those provided under the terms 
    of the plan. Moreover, HIPAA provides that a plan or issuer may 
    establish limitations or restrictions on the amount, level, extent, or 
    nature of the benefits or coverage for similarly situated individuals 
    enrolled in the plan. Comments have been received indicating that some 
    plans contain provisions that exclude coverage for benefits based on 
    the source of injury (such as benefits for injuries sustained
    
    [[Page 16903]]
    
    in a motorcycle accident, injuries sustained in a motorcycle accident 
    as the result of not wearing a helmet, or injuries sustained in the 
    commission of a felony). Accordingly, comments are requested on how 
    future guidance should treat benefit limitations based on the source of 
    an injury.
        The Conference Report also states that ``[t]he term `similarly 
    situated' means that a plan or coverage would be permitted to vary 
    benefits available to different groups of employees, such as full-time 
    versus part-time employees or employees in different geographic 
    locations. In addition, a plan or coverage could have different benefit 
    schedules for different collective bargaining units.'' Accordingly, 
    comments are requested concerning the appropriate standards for 
    determining ``similarly situated individuals,'' including whether a 
    plan is permitted to vary benefits based on an employee's occupation. 
    Because these standards could impact on the small group market, the 
    Department of Health and Human Services is particularly interested in 
    receiving comments from States with respect to how varying benefits 
    based on occupation could affect rate setting.
        The Departments also request comments regarding how the 
    prohibitions on discrimination should be applied between groups of 
    similarly situated individuals. For example, is guidance needed on 
    whether a plan covering employees in two different locations could have 
    a longer waiting period for employees at one location because the 
    health status of those employees results in higher health costs?
        A plan or issuer may not require any individual (as a condition of 
    enrollment or continued enrollment) to pay a premium or contribution, 
    that is greater than that for a similarly situated individual enrolled 
    in the plan, based on a health status-related factor. However, this 
    limitation does not restrict the amount that an issuer can charge an 
    employer for the coverage. In addition, this limitation does not 
    prevent a plan or issuer from establishing premium discounts or rebates 
    or otherwise modifying applicable copayments or deductibles in return 
    for adherence to programs of health promotion and disease prevention 
    (bona fide wellness programs). Comments are requested regarding the 
    standards for determining bona fide wellness programs, including 
    whether such a program may provide a discount for non-smokers.
    
    Special Rules--Excepted Plans and Excepted Benefits--26 CFR 54.9804-1, 
    29 CFR 2590.732, 45 CFR 146.145
    
        This section of the regulations provides special rules for certain 
    plans and certain benefits.
        Very Small Plans. The group market requirements of HIPAA do not 
    apply to a group health plan, or to group health insurance coverage 
    offered in connection with a group health plan, for any plan year if, 
    on the first day of the plan year, the plan has fewer than 2 
    participants who are current employees. However, a State may apply the 
    group market provisions in the PHS Act to plans with fewer than two 
    participants who are current employees. In this case, the State would 
    apply its group market insurance law requirements to such small group 
    plans (and such plans would not be subject to the individual market 
    requirements).
        Excepted Benefits. The group market provisions and the related 
    regulations also do not apply to any group health plan or group health 
    insurance issuer in relation to its provision of excepted benefits. The 
    benefits identified in paragraph (b)(2) are generally not health 
    insurance coverage and are excepted in all circumstances. In contrast, 
    the benefits identified in paragraphs (b) (3), (4), and (5) are 
    generally health insurance coverage but are excepted if certain 
    conditions are met.
        Limited-scope dental benefits, limited-scope vision benefits, and 
    long-term care benefits are excepted if they are provided under a 
    separate policy, certificate, or contract of insurance, or are 
    otherwise not an integral part of the plan. For this purpose, limited-
    scope dental coverage typically provides benefits for non-medical 
    services such as routine dental cleanings, x-rays, and other preventive 
    procedures. Such coverage may also provide discounts on the cost of 
    common dental procedures such as fillings, root canals, crowns, full or 
    partial plates, or orthodontic services. Limited-scope dental coverage 
    typically does not provide benefits for medical services, such as those 
    procedures associated with oral cancer or with a mouth injury that 
    results in broken, displaced, or lost teeth.
        Similarly, limited-scope vision coverage provides benefits for 
    routine eye examinations or the fitting of eyeglasses or contact 
    lenses. This coverage does not include benefits for such 
    ophthalmological services as treatment of an eye disease (e.g., 
    glaucoma or a bacterial eye infection) or an eye injury.
        Noncoordinated benefits may be excepted benefits. The term 
    ``noncoordinated benefits'' refers to coverage for a specified disease 
    or illness (such as cancer-only coverage) or hospital indemnity or 
    other fixed dollar indemnity insurance (such as insurance that pays 
    $100/day for a hospital stay as its only insurance benefit) if three 
    conditions are met. First, the benefits are provided under a separate 
    policy, certificate, or contract for insurance. Second, there is no 
    coordination between the provision of these benefits and another 
    exclusion of benefits under a plan maintained by the same plan sponsor. 
    Third, benefits are paid without regard to whether benefits are 
    provided with respect to the same event under a group health plan 
    maintained by the same plan sponsor.
        Certain supplemental benefits are excepted only if they are 
    provided under a separate policy, certificate, or contract of 
    insurance. This category of excepted benefits includes Medicare 
    supplemental (commonly called ``Medigap'' or ``MedSupp'') policies, 
    CHAMPUS supplements, and supplements to certain employer group health 
    plans. Such supplemental coverage cannot duplicate primary coverage and 
    must be specifically designed to fill gaps in primary coverage, 
    coinsurance, or deductibles.\14\
    ---------------------------------------------------------------------------
    
        \14\ Note that a group health plan, which provides primary 
    coverage while an individual is an active employee, is often 
    extended to retirees. When the retiree becomes eligible for 
    Medicare, the group health plan commonly coordinates with Medicare 
    and may serve a supplemental function similar to that of a Medigap 
    policy. However, such employer-provided retiree ``wrap around'' 
    benefits are not excepted benefits (because they are expressly 
    excluded from the definition of a Medicare supplement policy in 
    section 1882(g)(1) of the Social Security Act).
    ---------------------------------------------------------------------------
    
        The regulations do not address section 2721(e) of the PHS Act or 
    section 705(d) of ERISA relating to the treatment of partnerships (or 
    the application of the Code's group market rules to partnerships). 
    Comments are requested on these provisions, including how these 
    provisions coordinate with other provisions relating to self-employed 
    individuals and partnerships.
    
    F. Other Group Market Provisions\15\
    ---------------------------------------------------------------------------
    
        \15\ In this section (``Other Group Market Provisions''), 
    references conform to usage in 45 CFR Part 146, which uses ``HCFA'' 
    in place of ``Department of Health and Human Services'' or 
    ``Secretary of Health and Human Services'' and ``HCFA regulations'' 
    in place of ``PHS Act regulations.''
    ---------------------------------------------------------------------------
    
    Guaranteed Renewability in Multiemployer Plans and Multiple Employer 
    Welfare Arrangements--Section 703 of ERISA and Section 9803 of the Code
    
        Requirements relating to guaranteed renewability in multiemployer 
    plans
    
    [[Page 16904]]
    
    and multiple employer welfare arrangements are set forth in section 703 
    of ERISA and section 9803 of the Code (but not in the PHS Act). These 
    provisions state that a group health plan that is a multiemployer plan 
    or that is a multiple employer welfare arrangement may not deny an 
    employer whose employees are covered under such a plan continued access 
    to the same or different coverage under the terms of such plan, other 
    than for certain specified reasons. The Departments are not issuing 
    regulations under section 703 of ERISA or section 9803 of the Code at 
    this time, but anticipate issuing regulations under these sections and 
    solicit comments regarding these sections.
        In these provisions, the terms ``continued access'' and ``same or 
    different coverage'' are not defined. Comments are requested on how 
    rules under these provisions might address variations and changes in a 
    plan's benefit packages and contribution rates, differences in the 
    characteristics of multiemployer plans and multiple employer welfare 
    arrangements, and any possible implications for the financial integrity 
    of affected plans.
    
    Preemption of State Laws; State Flexibility--29 CFR 2590.731 and 45 CFR 
    146.190
    
        The McCarran-Ferguson Act of 1945 (Pub. L. 79-15) exempts the 
    business of insurance from federal antitrust regulation to the extent 
    that it is regulated by the States and indicates that no federal law 
    should be interpreted as overriding State insurance regulation unless 
    it does so explicitly. Section 514(a) of ERISA preempts State laws 
    relating to employee benefit plans (including group health plans). 
    However, section 514(b)(2) of the ERISA saves from preemption any State 
    law that regulates insurance. Section 2723 of the PHS Act and section 
    731 of ERISA make clear that Part A of Title XXVII of the PHS Act and 
    Part 7 of Subtitle B of Title I of ERISA do not in any way affect or 
    modify section 514 of ERISA.
        In addition, section 2723 of the PHS Act and section 731(a) of 
    ERISA preempt State insurance laws to the extent such laws ``prevent 
    the application of'' Part A of Title XXVII of the PHS Act and Part 7 of 
    Subtitle B of Title I of ERISA. (There is no corresponding provision in 
    the Code.) In this regard, the Conference Report states that the 
    conferees intended the narrowest preemption of State laws with regard 
    to health insurance issuers (not group health plans) with respect to 
    all the provisions of Part A of Title XXVII of the PHS Act and Part 7 
    of Subtitle B of Title I of ERISA (except for preemption with respect 
    to the provisions of section 2701 of the PHS Act and section 701 of 
    ERISA.) Consequently, the Conference Report states that State laws with 
    regard to health insurance issuers that are broader than federal 
    requirements in certain areas would not ``prevent the application of'' 
    the provisions of Part A of Title XXVII of the PHS Act or Part 7 of 
    Subtitle B of Title I of ERISA.
        However, the preemption is broader for the statutory requirements 
    of section 2701 of the PHS Act and 701 of ERISA that limit the 
    application of preexisting condition exclusions. State laws cannot 
    ``differ'' from the preexisting condition exclusion requirements of 
    section 2701 of the PHS Act or section 701 of ERISA, except as 
    specifically permitted under section 2723(b)(2) of the PHS Act and 
    section 731(b)(2) of ERISA. These specific exceptions permit a State to 
    impose on health insurance issuers certain stricter limitations 
    relating to preexisting condition exclusions.
        Comments are also solicited on issues relating to the coordination 
    of the new requirements under HIPAA and State requirements for 
    associations that may be multiple employer welfare arrangements as 
    defined in section 3(40) of ERISA.
    
    Guaranteed Availability of Coverage for Small Employers Under the PHS 
    Act Group Market Provisions--45 CFR 146.150
    
        Rules relating to guaranteed availability of coverage for employers 
    in the small group market appear only in the PHS Act (at section 2711). 
    In general, this section requires health insurance issuers that offer 
    coverage in the small group market to offer to any small employer all 
    of the products they actively market in that market. This is generally 
    referred to as an all-products guarantee. However, as allowed under 
    applicable State law, the issuer can require that the employer make a 
    minimum contribution toward the premium charged and have a minimum 
    level of participation by eligible individuals. The issuer must also 
    accept for enrollment every eligible individual without regard to 
    health status. For purposes of this section, an eligible individual is 
    one who meets the applicable requirements of the group health plan, the 
    issuer, and State law for coverage under the plan.
        Some States have, in recent years, made reforms in their small 
    group markets that only require guaranteed issue of a basic and a 
    standard policy, rather than an all-products guarantee. They have urged 
    that an all-products guarantee not be adopted, arguing that the law 
    does not specifically require it. However, sections 2711 and 2741 of 
    the PHS Act, as added by HIPAA, contain virtually identical 
    requirements requiring issuers that offer health insurance coverage in 
    either the small group or individual market to make ``such coverage'' 
    available to, respectively, small employers or eligible individuals. 
    While section 2741 explicitly permits issuers to limit to two policies 
    the offerings they are required to make in the individual market, the 
    small group market provisions contain no similar exception. In fact, 
    section 2713(b)(1)(D) requires that an issuer that offers health 
    insurance to any small employer must provide information concerning 
    ``the benefits and premiums available under all health insurance 
    coverage for which the employer is qualified.'' (Emphasis added.) This 
    indicates that Congress intended to require an all-products guarantee 
    in the small group market. (However, a State that implements an 
    ``alternative mechanism'' in the individual market under section 2744 
    of the PHS Act has the flexibility either to impose an all-products 
    guarantee or to use a completely different mechanism for making 
    insurance available to individuals guaranteed coverage under the 
    statute.)
        Various industry groups and persons responding to the notice that 
    the three Departments published on December 30, 1996 asked that the 
    term ``offer'' be interpreted to mean ``actively marketed,'' so that 
    issuers would not be required to reopen closed blocks of business. The 
    regulations make this clear.
        Section 2711 also requires issuers to accept for enrollment any 
    individuals who are eligible to enroll under the terms of the plan, and 
    who satisfy the requirements of the issuer and applicable State law, 
    during the period in which the individual ``first becomes eligible'' to 
    enroll under the terms of the group health plan. Thus, the issuer is 
    not required to accept late enrollees. The regulations make it clear 
    that this protection extends to individuals if they ``first become 
    eligible'' to enroll during a special enrollment period. The special 
    enrollment provisions of the statute evidence the intent that 
    individuals who qualify for special enrollment be given the same 
    protections given to newly-hired employees and their dependents.
    
    [[Page 16905]]
    
        An issue has also been raised as to whether the statutory 
    definitions of premium contributions and group participation rules, 
    which are repeated in the regulations, related only to percentages of 
    employees or premium dollars or to absolute numbers of employees or 
    premium amounts. If the latter interpretation were permitted, the 
    effect would be to undermine the all-products guarantee by allowing, 
    for example, some products to be available to ``larger'' small 
    employers, but not to the smallest employers. The regulations currently 
    leave interpretation of this language to the States, but comments are 
    welcomed on this issue.
        Section 146.150 also includes rules regarding the circumstances 
    under which issuers are permitted to deny coverage to employers. If the 
    product is a network plan, under which services are furnished by a 
    defined set of providers, the issuer can deny coverage to an employer 
    whose eligible individuals do not live, work, or reside in the network 
    plan's service area. It can also deny coverage if it has demonstrated 
    to the State that its network does not have the capacity to deliver 
    services to additional groups, but is then barred for 180 days from 
    offering coverage in that service area. An issuer may also deny 
    coverage if it demonstrates that it lacks sufficient financial reserves 
    to underwrite additional coverage, but is barred for 180 days from 
    offering coverage in the small group market in the State. Both of these 
    exceptions must be applied to all employers uniformly without 
    consideration of the health status or claims experience of an 
    employer's employees or dependents. Neither of these exceptions 
    relieves a network plan of its responsibility to continue servicing its 
    in-force business under the guaranteed renewability requirements of the 
    regulations.
        Finally, Sec. 146.150 provides that if the coverage is only made 
    available to members of ``bona fide associations'' as that term is 
    defined in the regulations, it is not subject to the guaranteed 
    availability requirements. (Accordingly, the coverage does not have to 
    be offered to non-members.) However, employers that obtain coverage 
    through a bona fide association are assured of guaranteed access to the 
    association's coverage options as long as they remain members of the 
    association. This is because a bona fide association cannot condition 
    membership in the association on health status-related factors. 
    Moreover, it must offer coverage to all employers who are members 
    without regard to health status-related factors relating to their 
    employees or dependents. Therefore, an association cannot legally 
    refuse enrollment to members on a selective basis so long as they meet 
    the association's membership criteria.
    
    Guaranteed Renewability of Coverage for Employers Under the PHS Act 
    Group Market Provisions--45 CFR 146.152
    
        Section 146.152 of the Health Care Financing Administration (HCFA) 
    regulations implements section 2712 of the PHS Act, which requires 
    issuers to renew or continue in force any coverage in the large or 
    small group market at the option of the plan sponsor. The exceptions to 
    this requirement include nonpayment of premiums, fraud, and violation 
    of minimum participation or contribution rules, as permitted under 
    applicable State law. Also, the issuer can cease to offer either a 
    particular product or all coverage it offers in the particular market, 
    and can refuse to renew if the group health plan's participants all 
    leave the service area of a network plan, or if the coverage is 
    provided through a bona fide association and the employer's membership 
    ends.
        Issuers that decide to discontinue offering a particular product or 
    all coverage in the small or large group market are subject to certain 
    requirements outlined in paragraphs (c) and (d) of this section of the 
    regulations. Issuers discontinuing only a particular product must give 
    90 days' notice, must offer the plan sponsor the option to purchase 
    other coverage the issuer offers in that market, and must discontinue 
    the product uniformly, without regard to claims experience or health 
    status of participants or dependents under a particular group health 
    plan. If the issuer terminates all coverage in a market or markets, it 
    must provide 180 days' notice to each plan sponsor, and it is 
    prohibited from issuing coverage in the market(s) or State involved for 
    five years following the date of discontinuation. Plans or issuers may 
    modify the health insurance coverage at the time of coverage renewal, 
    provided the modification is consistent with State law and, for the 
    small group market, is effective uniformly among group health plans 
    with coverage under that product.
        Some States have asked whether an issuer that chooses to stop 
    selling comprehensive products, such as a basic or standard policy, in 
    a particular State's group market, must also cease selling policies 
    consisting of excepted benefits. Because Congress permitted these types 
    of supplemental policies and limited benefit plans to be excepted from 
    the requirements of HIPAA in both the group and individual markets, 
    HCFA intends to defer to the States' judgment on this issue, and 
    solicit comments.
        State law may limit the extent to which an issuer can abandon a 
    product or market, and under what circumstances. For example, a State 
    may choose to require an issuer vacating the market to transfer its 
    business to another issuer through assumption reinsurance, or some 
    other means permitted under State law.
        Paragraph (g) of this section of the regulations provides that, 
    with respect to group coverage offered only through associations, the 
    option of guaranteed renewability extends to include employer members 
    of an association. This provision means that all employers covered by 
    an issuer through an association have the right to renew the coverage 
    they received if the association ceases to serve its members, 
    regardless of the reason.
    
    Disclosure of Information by Issuers to Employers Seeking Coverage in 
    the Small Group Market--45 CFR 146.160
    
        Section 146.160 of the HCFA regulations implements section 2713 of 
    the PHS Act by setting forth rules relating to disclosure of 
    information by issuers to employers seeking coverage in the small group 
    market. In its solicitation and sales materials, the issuer must make a 
    reasonable disclosure that the specified information is available on 
    request. The information that must be provided includes the issuer's 
    right to change premium rates and the factors that may affect changes 
    in premium rates, renewability of coverage, any preexisting condition 
    exclusion (including use of the alternative method of counting 
    creditable coverage), any affiliation periods applied by HMOs, the 
    geographic areas served by HMOs, and the benefits and premiums 
    available under all health insurance coverage for which the employer is 
    qualified under minimum contribution and participation rules, as 
    permitted by State law. The issuer is exempted from disclosing 
    proprietary or trade secret information under applicable law.
        ``Factors that may affect changes in premium rates'' and 
    ``proprietary and trade secret information under applicable law'' have 
    not been defined. Comments are requested regarding whether they should 
    be defined.
        The information described in this section must be provided in 
    language that is understandable by the average small employer and 
    sufficient to reasonably inform small employers of their rights and 
    obligations under the health insurance coverage. This requirement can 
    be satisfied by using as
    
    [[Page 16906]]
    
    a model the outlines of coverage provided under Medicare Supplement 
    insurance. (These outlines are required to provide easy comparison of 
    the coverage and cost of all available products.) Reasonable 
    information includes rating schedules for each product to which more 
    than one rate applies, and, with respect to network plans, maps of 
    service areas or lists of counties served.
    
    Exclusion of Certain Plans From the PHS Act Group Market Requirements--
    45 CFR 146.180
    
        Section 146.180 of the HCFA regulations implements section 2721 of 
    the PHS Act, which permits certain nonfederal governmental plans to 
    elect to be exempted from some or all of the group market requirements 
    of the HCFA regulations, although they are subject to the certification 
    and disclosure requirements of Sec. 146.115. With respect to nonfederal 
    governmental plans that are collectively bargained, this section does 
    not preempt State and local collective bargaining laws. The regulation 
    establishes the form and manner of the election, and requires a 
    nonfederal governmental plan making this election to notify plan 
    participants, at the time of enrollment and on an annual basis, that it 
    has made the election and what effect the election has. The participant 
    notice and certification and disclosure obligations are integral parts 
    of the election. Failure to comply with these obligations invalidates 
    an election and subjects the nonfederal governmental plan to the 
    requirements the election would have permitted the plan to avoid.
        Only nonfederal governmental plans that are self-funded (in whole 
    or in part) can make the election, and the election only applies to the 
    self-funded portion. A health insurance issuer that sells insurance 
    coverage to a nonfederal plan must comply with all the group market 
    requirements.
    
    Enforcement of PHS Act Requirements--45 CFR 146.184
    
        Part 146 imposes requirements on health insurance issuers that 
    offer coverage in the group market in a State, and on nonfederal 
    governmental (i.e., State and local) group health plans. With respect 
    to issuers, the statute makes it clear that it is solely within the 
    discretion of the States, in the first instance, whether to take on the 
    responsibility for enforcing those requirements or whether to leave 
    enforcement to the federal government. HCFA anticipates that the States 
    will choose to enforce the requirements. However, the statute also 
    makes clear that if a State does not substantially enforce the 
    requirements, HCFA must enforce them. The statute also requires HCFA to 
    enforce the requirements applicable to nonfederal governmental plans.
        Section 146.184(b)(2) sets forth the procedures that HCFA will 
    follow if a question is raised about the State's enforcement with 
    respect to issuers. Under the procedures, States are given every 
    opportunity to demonstrate why federal enforcement is not required. The 
    regulations also make it clear that the procedures will not be 
    triggered unless HCFA is satisfied that there has first been a 
    reasonable effort to exhaust any State remedies. However, if, after 
    giving the State a reasonable opportunity to enforce, HCFA makes a 
    final determination that a State is not substantially enforcing these 
    requirements, HCFA will enforce the requirements using the civil money 
    penalties provided for under the statute.
        Parargarph (d) describes the process for imposing civil money 
    penalties against issuers or nonfederal plans that fail to comply with 
    the group market requirements in the PHS Act. If HCFA receives a 
    complaint or other information that indicates that a right guaranteed 
    by the group market rules is being denied, HCFA will first determine 
    which entity is potentially responsible for any penalty. If the failure 
    is by an issuer, the issuer will be responsible. If a nonfederal 
    governmental plan is sponsored by a single employer, the employer will 
    be liable, but if the plan is sponsored by two or more employers, the 
    plan will be liable. If, after giving the entity or entities an 
    opportunity to respond, HCFA assesses a penalty, the regulation 
    provides appeal rights. The penalty can consist of up to $100 for each 
    day, for each individual whose rights are violated.
    
    Effective Dates--26 CFR 54.9806-1, 29 CFR 2590.736, 45 CFR 146.125
    
        The group market provisions are generally effective for plan years 
    beginning after June 30, 1997.\16\ In many cases, no preexisting 
    condition exclusion may be imposed with respect to an individual on the 
    effective date because any permitted preexisting condition exclusion 
    period is measured from the individual's enrollment date in the plan 
    (even if the enrollment date is before the statutory effective date). 
    An individual who has not completed the maximum permitted exclusion 
    period under HIPAA before the effective date for his or her plan may 
    use creditable coverage to reduce the remaining preexisting condition 
    exclusion period. The regulations contain examples illustrating the 
    effect of these rules.
    ---------------------------------------------------------------------------
    
        \16\ In the case of a group health plan maintained pursuant to 
    one or more collective bargaining agreements between employee 
    representatives and one or more employers ratified before August 21, 
    1996, the group market provision (other than the requirements to 
    provide certifications) do not apply to plan years beginning before 
    the later of July 1, 1997 or the date on which the last of the 
    collective bargaining agreements relating to the plan terminates 
    (determined without regard to any extension agreed to after August 
    21, 1996).
    ---------------------------------------------------------------------------
    
        The requirement that a plan or issuer provide certificates to show 
    creditable coverage applies to events occurring on or after July 1, 
    1996, except that in no case is a certificate required to be provided 
    before June 1, 1997 or to reflect coverage before July 1, 1996.
        For events occurring on or after July 1, 1996 but before October 1, 
    1996, a certificate is required to be provided only upon a written 
    request by or on behalf of the individual to whom the certificate 
    applies. For events occurring on or after October 1, 1996 and before 
    June 1, 1997, a certificate must be furnished no later than June 1, 
    1997 (or, if later, any date that would otherwise apply under the 
    standard rules).
        The regulations include an optional transition rule for events 
    before June 1, 1997. (The transition rule applies to automatic 
    certificate events; it does not apply where a certificate is 
    requested.) A group health plan or health insurance issuer offering 
    group health coverage is deemed to satisfy the automatic certificate 
    requirements if a special notice is provided no later than June 1, 
    1997. The notice must be in writing and must include information 
    substantially similar to the information included in a model notice 
    authorized by the Secretaries. For this purpose, the following model 
    notice is authorized:
    
    IMPORTANT NOTICE OF YOUR RIGHT TO DOCUMENTATION OF HEALTH COVERAGE
    
        Recent changes in Federal law may affect your health coverage if 
    you are enrolled or become eligible to enroll in health coverage 
    that excludes coverage for preexisting medical conditions.
        The Health Insurance Portability and Accountability Act of 1996 
    (HIPAA) limits the circumstances under which coverage may be 
    excluded for medical conditions present before you enroll. Under the 
    law, a preexisting condition exclusion generally may not be imposed 
    for more than 12 months (18 months for a late enrollee). The 12-
    month (or 18-month) exclusion period is reduced by your prior health 
    coverage. You are entitled to a certificate that will show evidence 
    of your prior health coverage. If you buy health insurance other 
    than through an employer group health plan, a certificate of prior 
    coverage may help you obtain coverage without a preexisting 
    condition exclusion. Contact your State insurance department for 
    further information.
    
    [[Page 16907]]
    
        For employer group health plans, these changes generally take 
    effect at the beginning of the first plan year starting after June 
    30, 1997. For example, if your employer's plan year begins on 
    January 1, 1998, the plan is not required to give you credit for 
    your prior coverage until January 1, 1998.
        You have the right to receive a certificate or prior health 
    coverage since July 1, 1996. You may need to provide other 
    documentation for earlier periods of health care coverage. Check 
    with your new plan administrator to see if your new plan excludes 
    coverage for preexisting conditions and if you need to provide a 
    certificate or other documentation of your previous coverage.
        To get a certificate, complete the attached form and return it 
    to:
    
    [Insert Name of Entity:]
    [Insert Address]:
    For additional information contact: [Insert Telephone Number]
    
        The certificate must be provided to you promptly. Keep a copy of 
    this completed form. You may also request certificates for any of 
    your dependents (including your spouse) who were enrolled under your 
    health coverage.
    
    REQUEST FOR CERTIFICATE OF HEALTH COVERAGE
    
    Name of Participant:---------------------------------------------------
    
    Date:------------------------------------------------------------------
    
    Address:---------------------------------------------------------------
    
    Telephone Number:------------------------------------------------------
    
        Name and relationship of any dependents for whom certificates 
    are requested (and their address if different from above):
    ----------------------------------------------------------------------
    
    ----------------------------------------------------------------------
    
        The provisions in the regulations relating to method of delivery 
    and entities required to provide a certificate apply with respect to 
    the provision of the notice. If an individual requests a certificate 
    following receipt of the notice, the certificate must be provided at 
    the time of the request as set forth in the regulations relating to 
    certificates provided upon request.
        HIPAA provides that no enforcement action is to be taken against a 
    group health plan or health insurance issuer with respect to a 
    violation of the group market rules before January 1, 1998 if the plan 
    or issuer has sought to comply in good faith with such requirements. 
    Compliance with the regulations is deemed to be good faith compliance 
    with the group market rules.
    
    G. Interim Rules and Request for Comments
    
        Section 707 of ERISA (redesignated as section 734 by section 
    603(a)(3) of the NMHPA), Section 2707 of the PHS Act, and Section 9806 
    of the Code added by HIPAA, provide, in part, that the Secretaries of 
    Labor, Treasury and HHS may promulgate any interim final rules as they 
    determine are appropriate to carry out the portability provisions of 
    HIPAA.
        Under Section 553(b) of the Administrative Procedure Act (5 U.S.C. 
    551 et seq.) a general notice of proposed rulemaking is not required 
    when the agency, for good cause, finds that notice and public comment 
    thereon are impracticable, unnecessary or contrary to the public 
    interest.
        These rules are being adopted on an interim basis because the 
    Secretaries have determined that without prompt guidance, some members 
    of the regulated community will have difficulty complying with the 
    HIPAA's certification requirements, and will be in violation of the 
    statute. Congress expressly intended that the certification and prior 
    creditable coverage provisions serve as the mechanism for increasing 
    the portability of health coverage for plan participants and their 
    beneficiaries. Without the Departments' guidance, plans would likely be 
    unable to produce the necessary amendments to plan documents reflecting 
    HIPAA's new requirements, as well as the appropriate certifications of 
    prior coverage that would help participants and beneficiaries reduce 
    any applicable preexisting condition exclusion periods imposed by a new 
    health plan. Thus, without the Departments' prompt guidance, 
    participants and beneficiaries will not have the benefit of a 
    convenient certificate of prior coverage to present upon changing 
    health coverage, and will likely have greater difficulty proving that 
    they are entitled to health coverage immediately, or soon after joining 
    a new health plan.
        Moreover, HIPAA's portability requirements will affect the 
    regulated community in the immediate future. HIPAA's certification 
    requirements are effective for all group health plans on June 1, 1997. 
    HIPAA's underlying requirements concerning establishing periods of 
    prior creditable coverage, pre-existing condition exclusion provisions, 
    and the special enrollment requirements, are generally applicable for 
    group health plans for plan years beginning on or after July 1, 1997. 
    Plan administrators and sponsors, and participants and beneficiaries 
    will need guidance on how to comply with the new statutory provisions 
    before these effective dates. These rules have been written in order to 
    ensure that plan sponsors and administrators of group health plans, as 
    well as participants and beneficiaries, are provided timely guidance 
    concerning compliance with these recently enacted amendments to ERISA, 
    the PHS Act and the Code. These rules provide guidance on these 
    statutory changes, and are being adopted on an interim basis because 
    the Departments find that issuance of such regulations in interim final 
    form with a request for comments is appropriate to carry out the new 
    regulatory structure imposed by HIPAA on group health plans and health 
    insurance issuers. In addition, these rules are necessary to ensure 
    that plan sponsors and administrators of group health plans, as well as 
    participants and beneficiaries, are provided timely guidance concerning 
    compliance with new and important disclosure obligations imposed by 
    HIPAA.
        Sections 101(g)(4), 102(c)(4), and 401(c)(4) of HIPAA also mandate 
    that the Secretaries issue regulations necessary to carry out the 
    portability amendments by April 1, 1997. Issuance of a notice of 
    proposed rule making with pubic comment thereon prior to issuing a 
    final rule could delay significantly the issuance of essential guidance 
    and prevent the Departments from complying with their statutory rule 
    making deadline. Furthermore, these rules are being adopted on an 
    interim basis and the Departments are inviting interested persons to 
    submit written comments on the rules for consideration in the 
    development of the final rules relating to HIPAA. Such final rules may 
    be issued in advance of January 1, 1998, after affording the public an 
    opportunity to review and comment.
        For the foregoing reasons, the Departments find that the 
    publication of a proposed regulation, for the purpose of notice and 
    public comment thereon, would be impracticable, unnecessary, and 
    contrary to the public interest.
    
    H. Regulatory Flexibility Act
    
        The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes 
    certain requirements with respect to rules which would have significant 
    economic impact on a substantial number of small entities. Section 603 
    of the RFA requires an agency publishing a general notice of proposed 
    rulemaking (NPRM) under section 553 of the APA to present at the time 
    of the publication of its NPRM an initial regulatory flexibility 
    analysis, describing the impact of the rule on small entities, and 
    seeking public comment on such impact.
        Small entities include small business, non-profit organizations, 
    and governmental agencies. A ``rule'' under the Regulatory Flexibility 
    Act is one for which a general notice of proposed rulemaking is 
    required under section 553(b) of the APA.
        Since these rules are issued as interim rules, and not as a general 
    notice of
    
    [[Page 16908]]
    
    proposed rulemaking, for the reasons stated above, an Initial 
    Regulatory Flexibility analysis has not been prepared.
        While these rules are being promulgated as interim final rules, the 
    Departments nevertheless invite interested persons to submit comments 
    for consideration in the development of the final rules regulating to 
    HIPAA. Consistent with the policy of the Regulatory Flexibility Act, 
    the public is encouraged to submit comments that suggest alternative 
    rules that accomplish the stated purpose of the statute and minimize 
    the impact on small entities. Specifically, the public in encouraged to 
    address:
         What information relating to prior coverage, preexisting 
    condition exclusion, health status, waiting periods and similar issues 
    do employers, plans and issuers currently rely on in maintaining health 
    care coverage systems?
         What are the estimated costs of complying with the 
    statute's requirements on certification of periods of prior creditable 
    coverage?
         How many small issuers offer products that may be subject 
    to the regulations? Is there an anticipated effect on these small 
    companies' competitiveness due to the regulations?
         To what extent do group health plans currently use service 
    providers to fulfill the administrative obligations, including 
    reporting and disclosure, previously imposed by ERISA? To what extent 
    would group health plans also use service providers to comply with this 
    regulation's certification requirements?
    
    I. Executive Order 12866, the Unfunded Mandates Reform Act and the 
    Small Business Regulatory Enforcement Fairness Act of 1995
    
        These rules have been determined to be a significant regulatory 
    action under Section 3(f) of Executive Order 12866. The following 
    analysis is consistent with Section 6(a)(3)(C) of the Order.
        These rules are not subject to the Unfunded Mandates Reform Act of 
    1995 (Pub. L. 104-4), because they are interim final rules. However, 
    consistent with the policy embodied in the Unfunded Mandates Reform 
    Act, the regulation has been designed to be the least burdensome 
    alternative for state, local and tribal governments and the private 
    sector, while achieving the objectives of HIPAA. In addition, the 
    following analysis provides information concerning the effects of the 
    regulation on state, local, and tribal governments and the private 
    sector.
        Throughout the regulatory process, HHS met and consulted with 
    representatives of affected state, local and tribal governments. These 
    groups include the National Association of Insurance Commissioners, the 
    National Governors' Association, the National Council for State 
    Legislatures, the Indian Health Service, and the American Public 
    Welfare Association. HHS also provided technical advice regarding its 
    interpretation of the statute to state insurance commissioners and 
    state legislatures at their request. Generally, these groups have 
    concerns regarding:
         The statute's preemption of state laws that would prevent 
    the implementation of statutory provisions;
         The burden on issuers and plans to implement the statutory 
    provisions, especially with regard to certification of prior creditable 
    coverage; and
         State's desires to have considerable flexibility in 
    complying with the statue, and continuing their traditional role as 
    regulators of insurance.
        After serious consideration of these concerns, HHS narrowly 
    interpreted the preemption of state law, taking the least burdensome 
    alternatives provided states considerable flexibility in complying with 
    the statute, and recognized the limited authority of federal agencies 
    in the regulation of health insurance.
        The Administrator of the Office of Information and Regulatory 
    Affairs of the Office of Management and Budget has determined that this 
    is a major rule for purposes of the Small Business Regulatory 
    Enforcement Fairness Act of 1996 (5 U.S.C. Section 801 et seq.).
        Set forth below is a discussion regarding the impact of the statute 
    and a discussion of the costs and benefits of the regulations 
    implementing the statute.
    
    J. Extensions of Coverage Under the Statute
    
        These regulations implement certain provisions of HIPAA. The 
    statute was enacted to, among other things, ``improve portability and 
    continuity of health care coverage in the group and individual 
    markets,'' as stated in the Conference Report. The statute accomplishes 
    these goals by instituting reforms in the group and individual 
    insurance markets, including provisions limiting the use of pre-
    existing condition exclusions, and requiring guaranteed access to 
    health care coverage and guaranteed renewability for certain groups and 
    individuals. There are also non-discrimination provisions and special 
    enrollment rights in the statute.
        The pre-existing condition exclusion periods that HIPAA restricts 
    are widespread. According to the Bureau of Labor Statistics (BLS), 46 
    percent of participants in private-sector, employer-sponsored health 
    plans are in plans with pre-existing condition exclusions (1993-1994 
    data). The same is true of 41 percent of participants in state and 
    local government employer-sponsored plans (1994 data.)
        The duration of exclusion periods varies from plan to plan. Based 
    on Peat Marwick's 1995 employer survey, an estimated 57 percent of 
    participants in plans with exclusions are in plans with exclusions that 
    last 12 months. The remainder are distributed as follows: 13 percent in 
    plans with 3-month exclusions, 22 percent in plans with 6-month 
    exclusions, 7 percent in plans with 9-month exclusions, and 1 percent 
    in plans with exclusions that last more than 12 months.
        HIPAA's portability provisions resemble provisions of many current 
    state laws. Importantly, however, HIPAA extends these provisions of 
    self-insured ERISA plans which federal law shields from state 
    regulation. In addition, it sets a minimum uniform threshold for 
    insured group plans and individual markets across all states.
        HIPAA's portability provisions will result in both direct and 
    social costs and benefits.
        In general, direct costs and benefits arise directly from the 
    application of HIPAA's insurance portability and access provisions. 
    Direct costs and benefits are often best understood as transfers of 
    resources among economic agents, which do not necessarily represent 
    changes in overall social welfare. Stated differently, they represent 
    changes in how the economic pie is divided (in this case, mainly with 
    respect to health care), and not changes in the size of the pie. Direct 
    costs and benefits are often easier to quantify than social costs, as 
    they are often directly observable as transactions in the marketplace.
        With respect to HIPAA's portability and access provisions, direct 
    costs and benefits arise from the extension of insurance coverage to 
    individuals and conditions not otherwise covered. Direct benefits to 
    individuals include the payment of individuals' claims for those 
    services and conditions. Direct costs of individuals include the 
    premiums associated with that coverage. Some available estimates of 
    these direct costs and benefits are presented below.
        Social costs and benefits, in contrast, do result in net changes in 
    overall social welfare. Social benefits generally reflect social 
    welfare gains that arise in
    
    [[Page 16909]]
    
    connection with statutory or regulatory interventions that remedy 
    market failure. Likewise, social costs generally reflect welfare losses 
    arising from interventions in otherwise efficient markets. Social 
    welfare changes often play out through a complex set of behavorial 
    responses to interventions. They are more difficult to quantify than 
    direct costs and benefits.
        With respect to HIPAA, social welfare changes generally arise 
    indirectly from HIPAA's portability and access provisions. They reflect 
    dynamic behavioral responses to HIPAA's portability and access 
    provisions. Expected social benefits, primarily improved access to 
    health insurance and also improved job mobility, cannot be meaningfully 
    quantified. Expected social costs, which could include erosions in 
    coverage arising from direct premium costs, are expected to be small. 
    Since no measures of HIPAA's many social welfare effects are available, 
    a mostly qualitative discussion of major effects is offered below. A 
    more quantitative discussion of direct costs and benefits follows 
    later.
    1. Social Welfare Effects of HIPAA's Portability and Access Provisions
        The primary direct benefits of the law are improved access to 
    insurance coverage, and more comprehensive coverage, through employers 
    and in the individual insurance market. Increased access and 
    comprehensiveness helps protect individuals from catastrophic expenses.
        There are a number of social benefits associated with improved 
    access:
         It reduces individual's risk of incurring large out-of-
    pocket costs;
         It is often more cost effective to provide timely 
    preventive and remedial care than to delay care until conditions 
    worsen. Therefore, to the extent that individuals receive more timely 
    and appropriate care as a result of HIPAA, over time, the long-term, 
    cumulative cost of their care may be lower. This has the potential to 
    reduce premiums for all individuals within a risk pool, not just the 
    individuals directly affected by HIPAA. Similarly, the Medicare program 
    may benefit from reduced expenditures because more individuals who 
    become newly entitled to Medicare will have had insurance coverage 
    during the course of their working life or through the individual 
    insurance market.
         To the extent that more timely care results in improved 
    health, worker attendance and productivity might improve.
         HIPAA's portability provisions likewise help individuals 
    transitioning from state and federal welfare programs to paid work. 
    Individuals with health conditions can offset their new health plan's 
    preexisting condition exclusions against prior coverage from any 
    source, including Medicaid.
         Reductions in job benefit both individuals and the economy 
    at large. Increased mobility can boost individual workers' career 
    opportunities. Increased mobility also strengthens U.S. economic 
    efficiency and competitiveness;
         HIPAA's federal minimum standards for small group and 
    individual access to insurance coverage may improve the functioning of 
    small group and individual markets. The standards will alleviate 
    disruptions that might otherwise arise when ``riskier'' groups and 
    individuals are denied or dropped from coverage.
         To the extent that HIPAA results, on net, in more 
    insurance payment for otherwise uncompensated care, cost-shifting and 
    associated inefficiencies in health care markets could be reduced.
        HIPAA's group-to-individual portability provisions may provide a 
    benefit for employees who move to jobs without health coverage. Some 
    small employers that do not currently offer health care coverage may be 
    able to do so more easily under HIPAA's guaranteed issue provisions. 
    This may help level the playing for small employers to compete with 
    larger ones in recruiting employees. While premium increases resulting 
    from HIPAA may reduce the affordability of coverage for some employers, 
    this effect is expected to be small, as noted below.
        HIPAA also requires that issuers offering health insurance coverage 
    in the individual market renew coverage for all individuals purchasing 
    health insurance coverage in the individual market, not only eligible 
    individuals. However, when an eligible individual elects family 
    coverage, the issuer may apply a pre-existing condition exclusion, 
    under applicable State law, to any of the individual's family members 
    who are not eligible individuals under the statute.
        The group-to-group portability regulation is likely to benefit 
    individuals who maintain employer-sponsored health benefit coverage and 
    change jobs or health plans, the dependents of such individuals, and 
    workers who face ``job lock'' due to health coverage concerns.
        Under HIPAA, health insurance coverage provided under a COBRA 
    continuation policy qualifies as group health coverage. This 
    distinction is particularly important for individuals moving from the 
    group to the individual market, or from one group health plan to 
    another, since electing this coverage would enable these individuals to 
    maintain continuous creditable coverage. In addition, individuals 
    seeking coverage in the individual market must elect and exhaust COBRA 
    continuation coverage in order to qualify as an ``eligible individual'' 
    in the individual market.
        Thus, the statute provide an additional incentive for those 
    individuals who lose coverage when they change jobs to elect COBRA 
    continuation coverage in order to avoid a break in coverage. The 
    statute also provides an incentive for those individuals who are 
    seeking coverage in the individual market without a preexisting 
    condition exclusion. Consequently, we expect more individuals to elect 
    COBRA continuation coverage.
        Absent HIPAA's group-to-group portability standards, individuals 
    with employer-sponsored health coverage who have preexisting medical 
    conditions and who change health plans could be denied coverage for 
    their conditions. In that case, individuals would have to pay out of 
    pocket for necessary medial services, or forgo some services, thereby 
    risking adverse health consequences and higher future costs. Other 
    individuals with preexisting medical conditions who change health plans 
    and face preexisting condition exclusions may pay for COBRA 
    continuation coverage in addition to paying for their new health plan 
    to ensure coverage for the preexisting condition. Other workers who are 
    concerned about losing health care coverage would stay in their jobs or 
    turn down job offers.
        According to the U.S. General Accounting Office, over 20 million 
    individuals changed jobs in 1993 (General Accounting Office, Report 
    HEHS-95-257, ``Health Insurance Portability: Reform Could Ensure 
    Continued Coverage for up to 25 Million Americans,'' September 1995, 
    pg. 7). Approximately 12 million of these workers had employer-
    sponsored health care coverage. Additionally, nearly 7 million non-
    working dependents received employer-sponsored health care coverage 
    through these job changers. According to GAO, many of these 20 million 
    could benefit from the regulation's requirement that prior health care 
    coverage be credited against a new health plan's preexisting condition 
    exclusion period. GAO concludes that the statute will allow 
    approximately 9 million job changers (who have at least 12 months of 
    prior creditable coverage), with 5 million dependents, to change jobs 
    without the
    
    [[Page 16910]]
    
    risk of facing any preexisting condition exclusions. Another 3 million 
    workers who change jobs (who have some smaller amount of prior 
    coverage), with 2 million dependents, would face reduced waiting 
    periods before receiving full coverage.
        The number of workers and dependents actually gaining coverage for 
    a preexisting condition due to credit for prior coverage following a 
    job change under HIPAA will be smaller than this, however. GAO's 
    estimates of people who could benefit include all job changers with 
    prior coverage and their dependents, irrespective of whether their new 
    employer offers a plan, whether their new plan imposed a preexisting 
    condition exclusion period, and whether they actually suffer from a 
    preexisting condition. Accounting for these narrower criteria, as 
    discussed below, CBO estimates that 100,000 will actually receive 
    additional coverage under HIPAA's credit for prior coverage at any 
    point in time.
        In addition, employers, especially smaller employers, that offer 
    health care benefits to their employees often change health insurance 
    issuers, exposing workers or their dependents with preexisting medical 
    conditions to gaps in coverage. Small employers generally change 
    insurance issuers every 3 to 4 years (Senate Committee on Labor and 
    Human Resources, Report 104-156, Oct. 12, 1995, pg. 4). The provisions 
    of the statute that allow crediting of prior coverage should reduce the 
    likelihood of gaps in coverage.
        One of the benefits of HIPAA to individuals is that it alleviates 
    ``job lock.'' That is, employees who have stayed in a particular job in 
    order to continue health care coverage can now change to a job that the 
    person might not otherwise have taken because he or she (or a 
    dependent) would have been subject to a pre-existing condition 
    exclusion; or the person can seek coverage in the individual insurance 
    market as a result of HIPAA's provisions requiring guaranteed issue for 
    individuals coming from the group market. According to the GAO, there 
    are one to four million Americans ``who at some time have been 
    unwilling to leave their jobs because of concerns about losing their 
    health care coverage'' (Health Insurance Portability: Reform Could 
    Ensure Continued Coverage for Up to 25 Million Americans, HEHS-95-257, 
    September 1995). The GAO notes that ``surveys have found that between 
    11 and 30 percent of individuals report that they or a family member 
    have remained in a job at some time because they did not want to lose 
    health care coverage.'' Among those individuals, twenty percent stated 
    that pre-existing conditions exclusions constituted the basis for their 
    reluctance to change jobs.
        These figures, reflecting individuals stated intentions, may not 
    accurately predict their behavior under different circumstances, 
    however. Moreover, HIPAA's portability provisions will alleviate only 
    some causes of ``job lock''--for example, employees might still be 
    somewhat impeded from taking jobs where no coverage is offered. 
    Eligible individuals might benefit in this case from HIPAA's group-to-
    individual portability provisions, but would have to pay the premium 
    themselves. Therefore, many individuals who report job lock will not 
    necessarily change jobs as a result of HIPAA.
        There also appears to be a difference by age categories of the 
    extent of job lock. The Health and Retirement Study (HRS), conducted by 
    the University of Michigan's Institute for Social Research, which 
    provides an emerging portrait of Americans age 51 through 61 and their 
    spouses, found that job flexibility is a key issue for this age group. 
    ``Almost three-quarters of HRS respondents would prefer to phase down 
    from full-time work to part-time work when they retire, in sharp 
    contrast to actual behavior, where most people who retire leave the 
    workforce entirely. About one-third of the people who would not look 
    for another job are victims of `job lock,' unable to leave because they 
    might give up valuable pensions or health insurance benefits if they 
    switched employers'' (HRS National Institute on Aging Press Release, 
    June 17, 1993).
        Empirical evidence for job lock is mixed. Buchmueller and Valletta 
    found strong evidence of job lock among women but weak evidence among 
    men (``The Effects of Employer-provided Health Insurance on Worker 
    Mobility,'' Industrial and Labor Relations Review, volume 49, number 3, 
    April 1996). Monheit and Cooper conclude that the magnitude and 
    importance of job lock, which some studies report as causing a 20 to 40 
    percent reduction in mobility, is not as great as generally thought 
    (``Health Insurance and Job Mobility: Theory and Evidence,'' Industrial 
    and Labor Relations Review, volume 48, number 1, October 1994). Kapur 
    found that job lock does not have a significant effect on job mobility 
    (``The Impact of Pre-existing Health Conditions on Job Mobility: A 
    Measure of Job Lock,'' WP-95-25, Institute for Policy Research), while 
    Gruber and Madrian found that COBRA continuation provisions, and 
    similar state laws (allowing individuals to continue coverage through 
    their employer group health plan for a specified period), have led to a 
    significant increase in job mobility (``Health Insurance and Job 
    Mobility: the Effects of Public Policy on Job-lock,'' Industrial and 
    Labor Relations Review, volume 48, number 1, October 1994).
        CBO does not quantify potential relief from ``job lock,'' which is 
    a social, rather than a direct, benefit of HIPAA. Because people freed 
    from job lock are going from one type of insurance to another (moving 
    to a different group health plan or to an individual insurance policy 
    under HIPAA portability), CBO also views freedom from job lock as 
    consisting of ``insured expenses * * * transferred among different 
    insurers * * * [that] * * * are not * * * direct costs.''
        The majority of evidence indicates that job lock is a concern for 
    many workers. HIPAA will address this concern, though the number of 
    workers who will gain an advantage is unclear and how the value of the 
    benefit can be measured is also unclear.
        As the forgoing discussion illustrates, HIPAA's social benefits are 
    expected to be far ranging, but they cannot be meaningfully quantified.
        HIPAA might also pose social costs. In particular, increases in 
    premiums under HIPAA's portability and access provisions could erode 
    coverage. These costs are expected to be small, however, particularly 
    in the group market where premium increases are estimated to be very 
    small relative to the overall market.
        In summary, HIPAA's portability and access provisions are expected 
    to result in a number of largely unquantifiable social benefits. These 
    include greater continuity of coverage, improved access to health care 
    and possible corollary improvements in health and productivity, 
    improved stability and efficiency in insurance health care markets, 
    eased movement from public assistance to work, and gains in job 
    mobility that are favorable to individual careers and to U.S. 
    competitiveness.
    2. Direct Costs and Benefits of HIPAA's Portability and Access 
    Provisions
        HIPAA's portability and access provisions impose direct costs and 
    provide direct benefits to a broad range of entities, as well as to 
    individual citizens. Costs will be incurred by employers, group plans, 
    insurance companies and managed care plans (``issuers''); states, in 
    their capacity as regulators, and states and localities as entities 
    providing health care coverage for their employees, retirees and 
    dependents; the federal government as regulator and as the source of 
    health care coverage for employees, annuitants and dependents, and for 
    others through programs such as Medicaid and
    
    [[Page 16911]]
    
    Medicare. Benefits will accrue to individuals and to small employers 
    whose access to comprehensive insurance is improved.
        A number of studies have evaluated the direct economic impact of 
    the law. The CBO found that ``to the extent that states have not 
    already implemented similar rules, these changes would clarify the 
    insurance situation and possibly reduce gaps in coverage for many 
    people.''
        The CBO notes that because HIPAA does not impose limits on premiums 
    issuers may charge, insurance coverage, though available, may be 
    expensive. Consequently, CBO observes that the law would ``make 
    insurance more portable for some people, [but] it would not 
    dramatically increase the availability of insurance in general.'' The 
    controversial question of the extent to which there will be increases 
    in issuer premiums is discussed more extensively below.
        CBO prepared estimates of the direct effects of the provisions of 
    the legislation included in these regulations (Letter to the Honorable 
    Bill Archer, August 1, 1996; notes are also from earlier CBO cost 
    estimates; see table below). The direct cost estimates can reasonably 
    be read as representing direct benefits as well, since they generally 
    reflect transfers from a pre-HIPAA payer to a post-HIPAA payer. Certain 
    medical expenses that individuals would pay out of pocket absent HIPAA 
    will be paid by insurance programs under HIPAA. In CBO's estimates, 
    this is reflected as a similar transfer in responsibility for payment 
    from individuals to insurance programs. However, the actual transfer 
    would be more complex. For example, to pay the additional claims, 
    insurers must collect additional premiums, which in turn will be paid 
    by the individuals gaining greater coverage and (in most cases) by 
    other covered individuals, or by their employers. CBO's estimates 
    represent gross costs to plans and gross benefits to individuals, and 
    do not account for these complexities.
    
                                    CBO Cost Estimates and Number of People Affected                                
    ----------------------------------------------------------------------------------------------------------------
                                             Yearly cost (direct        Number of people                            
                  Provision                cost to private sector)          affected         Other effects; comments
    ----------------------------------------------------------------------------------------------------------------
    Group: Limiting Length of Pre-         $50 million in first     300,000 people ``would   Assumes ``surge'' in   
     Existing Condition Exclusions to 12    year (1997); $200        gain coverage'' at any   claims costs; state   
     Months.                                million per year in      point in time, or 0.3%   laws taken into       
                                            subsequent years.        of people with private   account.              
                                                                     employment-based                               
                                                                     coverage.                                      
    Group: Creditable Coverage Reducing    $25 million in first     100,000 people ``would   Small No. of people    
     Pre-Ex.                                year; $100 million per   receive added            affected reflects     
                                            year thereafter.         coverage'' at any        ``restrictive         
                                                                     point in time.           eligibility           
                                                                                              criteria''.           
    Group: Above two combined............  $300 million...........                                                  
    (1)Comments: about .2% of total                                                                                 
     premiums in group and employer-                                                                                
     sponsored market; but may be                                                                                   
     overstated because HMOs, now the                                                                               
     dominant option, often do not use                                                                              
     pre-ex exclusions.                                                                                             
    Individual (group-to-individual        $50 million............  45,000 people covered    Provisions would apply 
     portability, no pre-existing                                    by end of first year.    in states that        
     condition exclusion, no denial                                                           currently have 5.4    
     because of health condition,                                                             million of estimated  
     guaranteed renewal). First year                                                          13.4 million people in
     estimates.                                                                               indiv. market (but see
                                                                                              analyses below).      
    Individual: Subsequent years.........  $200 million by fifth    ``In about four years,   Level of premiums to be
                                            year.                    the number of people     charged is unknown;   
                                                                     covered; would plateau   states may limit      
                                                                     at around 150,000''.     allowable premiums,   
                                                                                              but such limits may   
                                                                                              impose indirect costs.
    ----------------------------------------------------------------------------------------------------------------
    
        Virtually all of the insurance market reform provisions of HIPAA 
    that are implemented through these regulations have the potential to 
    increase premiums in the group market. Group plans may have to bear 
    higher costs because of the statutory limits on pre-existing condition 
    exclusions and the creditable coverage provisions reducing the 
    application of permissible pre-existing condition exclusions. CBO has 
    estimated the total costs of these two provisions at $300 million 
    annually after full implementation, or 0.2% of total premiums in the 
    group market. This reflects coverage for services which would have been 
    excluded under current law due to pre-existing condition exclusions in 
    insurance contracts, but which would be covered under HIPAA due to 
    HIPAA's 12-months cap on exclusions and its provisions requiring credit 
    for prior coverage.
        CBO's $300 million cost figure reflects only the costs of the 
    statute's limits on pre-existing conditions exclusion, and its prior 
    creditable coverage provisions. It does not include the administrative 
    costs to plans and issuers of the HIPAA's certification requirement, 
    which the Department of Labor has measured in its Paperwork Reduction 
    Act analysis below. Similarly, CBO's $300 million figure does not 
    include any other increased premium costs that might be associated with 
    the statute's health status nondiscrimination or guaranteed 
    renewability provisions. CBO's figure does try to estimate (a) how many 
    people would benefit from the statute's limits on preexisting condition 
    exclusions, and its prior creditable coverage provision, and (b) the 
    average cost to insurers of the extension of coverage to those 
    individuals.
        Preexisting condition exclusion limitation: CBO derived its $300 
    million figure by estimating that approximately 300,000 people with 
    private employment-based coverage would gain coverage under the 
    statute's preexisting condition exclusion limitation provision, at a 
    direct private sector cost of $200 million per year. CBO adjusted this 
    estimate to exclude people who reported being limited by a preexisting 
    condition restriction, but who also had secondary health coverage to 
    pick up the cost of their preexisting condition. CBO reasoned that 
    under these circumstances, the preexisting condition exclusion 
    limitation would not raise the aggregate costs imposed on employment-
    based plans. CBO likewise adjusted its estimate to reflect the 
    existence of state laws which limited preexisting condition exclusion 
    limitations to one year or less and require that previous coverage be 
    credited against those exclusions. These state laws generally apply to 
    group plans of 50 or fewer employees, and do
    
    [[Page 16912]]
    
    not include self-funded health benefit plans subject to ERISA rather 
    than state laws. Since plans covered by such state laws would not have 
    to change their provisions as a result of HIPAA, CBO lowered its 
    initial estimate of the people affected by the bill.
        Crediting Prior Coverage: CBO's $300 million figure also includes 
    an estimate that 100,000 people, at a private sector cost of about $100 
    million per year, would receive some added coverage as a result of 
    HIPAA's prior creditable coverage provision.
        CBO reports that these estimates are subject to considerable 
    uncertainty for several reasons. First, they are based on individuals' 
    responses to surveys, which should be treated with caution. Likewise, 
    unforeseen changes in the health insurance market, such as changes in 
    medical costs or the growth of managed care plans, could raise or lower 
    the direct costs of the law. Increases in medical costs would obviously 
    raise the costs, while the expansion of HMO penetration in the market 
    would tend to reduce the law's effect, since HMOs generally do not use 
    preexisting condition exclusions.
        CBO also reports that in particular, distribution of the costs 
    these provisions would be uneven across health plans. CBO notes that 
    ``[o]nly plans that currently use pre-existing condition exclusions of 
    more than 12 months would face the $200 million direct costs of the 
    statute's exclusion limitation.'' Data from a Peat Marwick survey used 
    by CBO indicate that 2.5% of employees are in such plans. Consequently, 
    ``the costs to health plans that use long preexisting condition 
    exclusions would be about 4.5% of their premium costs.'' Likewise, only 
    those plans that use preexisting condition exclusions would face the 
    $100 million direct cost of the mandate to credit prior coverage 
    against the preexisting conditions exclusion. CBO reports that ``almost 
    half of employees are in such plans--implying that the plans directly 
    affected by this mandate would have direct costs equal to about one-
    tenth of one percent of their premiums'' absent the statute.
        The increased costs may be shared by insurers, plans, and insured 
    individuals. Additionally, costs also may be borne directly by plans 
    that an issuer ``experience rates,'' i.e. the insurer determines rates 
    according to the utilization of the group being insured. Costs may also 
    be borne by others insured through an issuer that uses some form of 
    community rating, which spreads risk over a greater number of ``insured 
    lives'' beyond the particular group that is the source of the 
    additional costs. To a certain extent, a group may have a choice in the 
    degree of burden: if the group knows that its members incur lower costs 
    than the average of the issuer's pool, the group can avoid a community-
    rated pool by becoming self-insured.
        There is also the possibility that group market premiums may 
    increase as a result of the HIPAA reforms in the individual market if 
    insurers spread the costs of claims in the individual market across a 
    pool that includes group members. HIPAA expressly provides for this 
    possibility as one of the elements of an acceptable state alternative 
    mechanism. (Such issues relating to the individual market are discussed 
    in more detail below.)
        Assuming that the CBO is correct in projecting that the premium 
    effect translates into 0.2 percent of total premiums in the group 
    market, a minimal premium effect is likely.
        CBO did not quantify the cost of nondiscrimination or special 
    enrollment provisions.
        With respect to nondiscrimination, approximately 135,000 workers 
    reported in 1993 that they were excluded from their employer's health 
    plan because of their health, according to DOL tabulations of the April 
    1993 Current Population Survey. In general, HIPAA would require plans 
    to offer benefits to such individuals.
        With respect to special enrollments, HIPAA provides that 
    individuals, under certain conditions, are permitted to enroll for 
    health coverage on the same terms as new participants, rather than as 
    late enrollees. The conditions triggering eligibility for special 
    enrollment generally include events in which an individual loses 
    coverage (such as when a spouse changes jobs when couples legally 
    separate or divorce) or joins a family that is eligible for coverage 
    (through marriage, birth, or adoption).
        Special enrollment requirements benefit individuals. Absent this 
    provision, eligible individuals could be subject to pre-existing 
    conditions exclusion periods of up to 18 months, and therefore would 
    might need 18 months of prior creditable coverage to fully offset a 
    preexisting condition exclusion period. Under the provision, eligible 
    individuals' exclusion periods are limited to 12 months. This special 
    enrollment provision also permits eligible individuals to enroll 
    immediately in plans which otherwise prohibit late enrollment, or which 
    allow late enrollments only during annual open enrollment periods.
        Considering some of the major groups that could benefit, the 
    Departments estimate that 734,000 families would gain eligibility for 
    special enrollments due to marriage, as would 701,000 due to births, 
    and 292,000 due to job changes in the family. These estimates, based on 
    the Survey of Income and Program Participation, reflect an annual count 
    of such events following which the relevant spouse or new born was 
    uninsured, or covered under an individual policy or Medicaid.
        Special enrollments may result in a marginal increase in aggregate 
    premiums and claims paid, but no change in average premium levels for 
    any one individual, since eligible individuals are not likely to have 
    any higher health care costs than the average new health plan 
    participant.
        In summary, HIPAA's portability and access provisions will result 
    in a number of direct costs and benefits. These direct costs represent 
    transfers among parties and not changes in overall social welfare. CBO 
    estimates that HIPAA's group portability provisions will result in $300 
    million of additional annual direct costs to insurance programs, which 
    in turn represents a direct benefit of $300 million in added coverage 
    for individuals. Additional direct costs and benefits will arise from 
    similar extensions of coverage under HIPAA's group-to-individual 
    portability, special enrollment, and nondiscrimination provisions. 
    Various estimates of the costs and benefits of the group-to-individual 
    provisions are offered below. Costs and benefits of the special 
    enrollment and nondiscrimination provisions have not been quantified.
    
    3. Affected Market Segments
    
    (1). Impact on State, Local and Tribal Governments
        The statute establishes federal standards and allows for federal 
    enforcement in an area that has traditionally been the domain of the 
    states, the regulation of insurance. However, the statute also permits 
    states to use alternative, state-specific mechanisms to achieve greater 
    portability and continuity in a manner similar to the federal 
    standards. Many states have undertaken insurance reforms similar to the 
    HIPAA provisions and are likely to seek approval for the continuation 
    of these alternative mechanisms. The statute provides that enforcement 
    of the requirements of the law will be the responsibility of the states 
    (for those states implementing alternative mechanisms as well as for 
    those states implementing the federal standards), unless a state is 
    unwilling or unable to enforce the law. Only in the latter case of 
    unwillingness or inability to enforce the law will the federal
    
    [[Page 16913]]
    
    government implement and enforce the law in a given state. It is highly 
    unlikely that there will be any instance of the federal government 
    assuming such a role, with the exception perhaps of the territories. 
    There is no federal financial assistance or resources to implement 
    these provisions.
        The CBO has generally determined that there will be a negligible 
    impact on these governmental entities, even in the event that, in their 
    capacity as sponsor of employee health care coverage, they choose not 
    to ``opt out'' of having certain provisions of the statute apply to 
    them. HIPAA provides that states and localities that self-insure their 
    health care coverage for employees, are permitted, under the statute, 
    to ``opt out'' of the provisions of the law affecting them with respect 
    to rules governing pre-existing condition limitations. Some entities 
    that have the option available will ``opt out.'' However, this does not 
    relieve them of the responsibility of providing certifications of 
    creditable coverage for their covered individuals. HIPAA does not 
    preempt state and local government collective bargaining laws. If there 
    were no opt-out entities, CBO projects that state and local governments 
    would see an increase in health care costs of less than $50 million, or 
    0.1% of the $40 billion annually in state and local total health 
    insurance expenditures.
        Those who would benefit from the imposition of HIPAA requirements 
    on state and local governments are individuals who are subject to a 
    pre-existing condition exclusion that would have been shortened in 
    length by HIPAA either under the 12-month limit or the crediting or 
    prior creditable coverage provision. As the CBO points out, this 
    benefit (for some) is coupled with a cost to (all covered) individuals 
    because it is assumed that states and localities would pass the cost 
    off to their employees through reduced compensation or benefits.
        According to CBO, the impact of the law on the states in their 
    capacity as regulators enforcing new insurance provision is marginal. 
    For states that have been enacting insurance reform measures in the 
    small group and individual markets, it could be argued that HIPAA 
    provides a benefit to the extent that the introduction of federal 
    standards facilitates the states' ability to continue insurance reforms 
    in these markets. According to the Intergovernmental Health Policy 
    Project (IHPP), in a report dated June of 1996, all but two states had 
    enacted some type of small group market reform, and 35 states had 
    enacted some type of individual insurance market reform. The presence 
    of a federal standard that may be viewed as constituting a ``floor'' of 
    requirements imposed on issuers in these two markets may also benefit 
    the states.
        The individual insurance market has traditionally been regulated by 
    the states, and Congress intended that, to the maximum extent possible, 
    the states should continue this regulatory role. To this end, the law 
    provides states with these options: (1) implement an alternative, 
    state-specific mechanism to ensure access to individual health care 
    coverage; (2) adopt and administer the federal standards of HIPAA; or 
    (3) allow the federal government to administer the law.
        In devising the first option, the implementation of an alternative 
    mechanism, Congress afforded states a good deal of flexibility in 
    establishing an alternative mechanism. At least 30 states are expected 
    to implement alternative mechanism, each unique to the state's 
    demographics and market conditions. States are encouraged to explore 
    innovative options and intend to afford states as much flexibility as 
    possible in the design of their alternative mechanisms. Throughout the 
    process of reviewing proposed alternative mechanisms, the states' need 
    for flexibility must be balanced with the rights of the individuals 
    afforded protection under the law.
        Our main concern is that the primary goal of HIPAA be achieve: that 
    eligible individuals are guaranteed coverage in the individual market, 
    to the extent that policies are available, without a preexisting 
    condition exclusion period. HHS intends to review states' mechanisms 
    with this goal in mind; so the information presented should present a 
    clear picture of the mechanism's impact on eligible individuals. The 
    information requested in these regulations (section 148.126(h)) closely 
    parallels the statutory provisions. While such information collection 
    requirements may impose a burden on each state that chooses to 
    implement an alternative mechanism, such information is necessary in 
    order to effectively evaluate the mechanism and ensure that the 
    mechanism will provide eligible individuals the protection guaranteed 
    by the law.
        The states are unlikely to choose the option whereby the Secretary 
    (HCFA) implements and enforces HIPAA in the states. Eight states, 
    however, may choose the ``federal fall-back'' option of incorporating 
    the HIPAA standards into state law rather than developing an 
    alternative mechanism.
        The statutes provides that a state is presumed to be implementing 
    an acceptable alternative mechanism as of January 1, 1998, unless the 
    Secretary of HHS notifies a state of her disapproval of the mechanism 
    by July 1, 1997. In states where the legislature does not meet in a 
    regular session between August 21, 1996 and August 20, 1997, the state 
    is presumed to be implementing an acceptable alternative mechanism as 
    of July 1, 1998. To our knowledge, only Kentucky qualifies for this 
    exception. The statute also provides an extension. Before making an 
    initial determination, HHS intend to make every effort to consult with 
    the appropriate state officials. After consultation with appropriate 
    state officials, should there still be cause for disapproval, HHS will 
    allow the state a reasonable opportunity to revise the mechanism or 
    submit a new mechanism. Throughout this process, HHS may require 
    further information from state officials regarding particular aspects 
    of their insurance market reform. While such requests for information 
    may also impose an additional burden on the state, this information 
    will be necessary to insure that the mechanism will provide the 
    protections guaranteed to eligible individuals under the law.
        As required by law, the Secretary of HHS will review each 
    alternative mechanism every three years. In this respect, the 
    regulation adheres closely to the statutory burden and merely clarified 
    that resubmission is required on every three-year anniversary of the 
    last submission date. HHS has also provided a process for review of 
    future mechanisms, should a state may wish to revise an existing 
    mechanism or propose a new mechanism.
        In addition to implementing an alternative mechanism, a state may 
    choose to adopt and administer the federal statutory provisions. Our 
    regulations in this regard do not differ from the statutory provisions. 
    As noted above, it is likely that up to eight states would choose this 
    option.
        Finally, a state may choose to allow the federal government to 
    administer the federal statutory provisions in the state. Although this 
    is a possibility contemplated in the statute, it is unlikely that any 
    state would choose this option. However, the impact of the regulations 
    that implement this option is discussed below.
        In states that have an acceptable alternative mechanism for 
    ensuring access to individual insurance or health care coverage, the 
    implementation of laws and determination of compliance with those laws 
    is exclusively a state matter. For other states, HIPAA gives the 
    Secretary authority to issue
    
    [[Page 16914]]
    
    regulations to carry out the implementation and enforcement of HIPAA 
    provisions for the states that choose the ``federal fallback'' option 
    (using federal standards), and for states in which the federal 
    government will directly administer the HIPAA provisions. These 
    regulations specify the following:
         Documentation that must be submitted to the state (federal 
    default) or to HCFA (direct regulation by the federal government) 
    demonstrating compliance with the statute;
         The manner in which an insurer markets individual 
    policies;
         The procedure and time frames the issuer follows in 
    determining whether someone is an eligible individual, and the 
    effective date of the individual's coverage;
         The procedure to follow for a request to limit enrollment 
    in the case of an HMO's or insurer's capacity limitations (network 
    capacity or financial capacity); and
         The procedure for determining whether the benefit packages 
    offered in the individual market are consistent with statutory 
    requirements.
        In states electing the federal fall-back approach, the state 
    determines the level of documentation required to establish compliance 
    with the HIPAA provisions. The Departments do not know the extent of 
    burden states will impose on plans as a result of HIPAA. Although there 
    is not likely to be direct federal enforcement in any state, in those 
    states in which HCFA does administer the law, issuers have 90 days 
    after July 1, 1997, to provide documentation concerning individual 
    policy forms the issuer already markets; and 90 days prior to the 
    beginning of the calendar year prior to marketing a new policy form. 
    With regard to these time frames, the 90-day period should not be 
    burdensome. Much of the information required to be submitted regarding 
    the policy forms in the individual market is material the issuer will 
    generally have filed with a state insurance commissioner (``information 
    on all products offered in the individual market''; marketing material, 
    often submitted to states on a ``file and use,'' or informational 
    basis). For such information the submission to the federal government 
    is burdensome only in that it is duplicative of material given to the 
    state. The HIPAA-specific materials are generally not duplicative and 
    constitute a burden on issuers to provide HCFA with the following 
    information:
         An explanation of how the issuer is complying with the 
    provisions of HIPAA, including how the issuer will inform eligible 
    individuals of available policy forms;
         Premium volumes or actuarial values (depending on which 
    election is made regarding compliance with rules on the type of policy 
    to be offered); and
         A description of the risk spreading/financial 
    subsidization mechanism to be used for individual policy forms.
        The last two items represent requirements of the statute, while the 
    first item is necessary to ensure that there is effective 
    implementation of the statute. For the first item, issuers will have to 
    become familiar with the provisions of HIPAA in order to comply with 
    the documentation requirement, which can be a considerable burden, but 
    the other information requirements should not be burdensome. One way in 
    which these regulations lessen the burden for plans electing to offer 
    ``representative coverage'' rather than the most popular policy forms 
    is by not prescribing the method of determining the actuarial value of 
    representative coverage. Issuers may make their own determinations of 
    actuarial value and present them to HCFA for verification.
    (2). Impact of the Law in Different States
        The impact of the law on individuals, employers, group plans, and 
    issuers may vary somewhat from state to state. Many state reforms 
    resemble HIPAA's portability provisions, often meeting or exceeding 
    particular HIPAA standards. The CBO notes that it ``lowered its initial 
    estimate of the number of people affected by the bill'' in recognition 
    of such state reforms. Where state laws resembling HIPAA exist, the 
    marginal impact of HIPAA is reduced.
        The degree to which a state's reforms lessen the impact of HIPAA's 
    portability provisions depends on the degree to which the state's 
    requirements exceed these provisions, and on what proportion of insured 
    individuals in the state are covered by the state's reforms. In 
    general, individuals not covered by state reforms are those enrolled in 
    programs for which such state reforms are preempted by federal law. 
    These include individuals enrolled in federal programs such as Medicare 
    and the Federal Employees Health Benefits Program or in self-insured 
    ERISA plans. Individuals enrolled in ERISA plans that are not self 
    insured are covered by such state reforms that are specifically saved 
    from preemption by HIPAA.
        According to a study by Jacob Klerman of RAND, New Estimates of the 
    Effect of Kassebaum-Kennedy's Group-to-Individual Conversion Provision 
    on Premiums for Individual Health Insurance (1996), 42 states have 
    guaranteed issue rules in the individual market or a high-risk pool 
    that could qualify the states as meeting the alternative mechanism 
    requirements of HIPAA. This is consistent with other information the 
    Departments have received to the effect that only eight states may 
    adopt the federal HIPAA standards (to be administered by the states). 
    (The individual market issues are discussed in greater detail below.)
        An analysis prepared by staff of the Pension and Welfare Benefits 
    Administration (PWBA) of the Department of Labor found, for the group 
    market, that 41 states have small group guaranteed issue; of that 
    number five do not conform with (or are not more generous than) HIPAA 
    rules on guaranteed issue, and 21 define a small group differently from 
    HIPAA by starting the small group category at three individuals (rather 
    than HIPAA's two)--the situation in 11 states--or by extending the 
    provisions to groups not reaching HIPAA's 50 (4 states define a small 
    group as up to 49; one as 40; and ten as either 24 or 25). These states 
    are likely to make relatively small changes as necessary to conform 
    their laws to HIPAA standards. The National Association of Insurance 
    Commissioners has also engaged in extensive efforts to help the states 
    conform their laws.
        Thirty-one states already have provisions which require that group 
    health plans offer additional enrollment opportunities to employees 
    under circumstances similar to HIPAA's special enrollment 
    opportunities. The statute expands the state baseline by adding legal 
    separation as a grounds for special enrollment eligibility, and 
    expressly includes COBRA as prior group health coverage. The statute 
    further requires retroactive coverage for newborns and adopted children 
    if special enrollment is requested within 30 days of birth, placement 
    for adoption, or adoption. Current state requirements reduce the 
    overall economic impact of the special enrollment requirements on the 
    group health market.
        For pre-existing conditions limitations in group health plans, 
    HIPAA provides that the maximum allowable period is 12 months (``look-
    forward''), or 18 months for a late enrollee (someone enrolling outside 
    of an initial or special enrollment period) for conditions arising 
    within the six months (``look-back'') preceding the enrollment date in 
    a group health plan. HIPAA also provides that prior coverage for which 
    there was not a break in coverage of 63 days or more would be credited 
    against the pre-existing condition exclusion. Using the PWBA analysis 
    and information from the IHPP,
    
    [[Page 16915]]
    
    as of mid-1996, 30 states had time limits on pre-existing condition 
    exclusion periods that are the same as, or more favorable to 
    individuals, than the HIPAA provisions for the group market; and 14 
    other states have limits on pre-existing condition time limits. Among 
    these 44 states, ten states allow crediting or prior coverage for which 
    the duration of the break in coverage equals or exceeds 63 days (more 
    generous than HIPAA); eight states allowed breaks in coverage of 60 
    days; 18 states allowed 30 or 31 days of a break in coverage; and four 
    states had no crediting of prior coverage. State laws which exceed 
    HIPAA standards will not be pre-emptied by HIPAA.
    (3). Group Plans
        HIPAA sets minimum standards for all group health plans, including 
    self-funded plans that are shielded by ERISA from states' HIPAA-like 
    requirements. The General Accounting Office has estimated that about 
    27% of the Nation's population received health care coverage through 
    ERISA self-funded plans (17%).
        Although the GAO report indicated that the number of people covered 
    by self-insured plans is increasing, other data indicate that there has 
    been a decline in such coverage because of the increasing number of 
    individuals covered by HMOs that operate as insured plans. However, an 
    HMO network may constitute an exclusive provider organization for a 
    self-insured plan. Liston and Patterson (Analysis of the Number of 
    Workers Covered by Self-Insured Health Plans Under the Employee 
    Retirement Income Security Act of 1974--1993 and 1995, prepared for the 
    Henry J. Kaiser Family Foundation, August 1996) found that from 1993 to 
    1995 the number of Americans covered by fully or partly self-insured 
    plans declined from 37.6 million to 32.5 million (a 14% decline). The 
    rate of decline was greatest in smaller firms: for firms with fewer 
    than 100 workers, the number of workers covered under fully or 
    partially self-insured plans declined form 8.2 million to 5.4 million 
    (a 34% decline). For firms with 25 or fewer employees, the numbers 
    declined from 2.9 million to 2.2 million from 1993 to 1995 (a 24% 
    decline).
        The relevance of these numbers to an analysis of HIPAA has to do 
    both with the number of people that can potentially benefit from the 
    HIPAA provisions (if the employees moving to ERISA-insured plans are in 
    states that already have provisions similar to HIPAA, effects will be 
    smaller), as well as the related issue (partially a consequence of the 
    former) of the extent to which the small group market in a given state 
    may be ``disrupted'' because of the effects of HIPAA. (For example, 
    will the HIPAA provisions create a situation in which either insurers 
    will abandon markets or employers will discontinue health care 
    coverage?) Although the Departments' economic impact analysis does not 
    contain a state-by-state analysis of the relationship between employees 
    covered under self-insured plans (and any changes in those numbers) and 
    the states that have reforms similar to HIPAA, Liston and Patterson 
    found that the South was the only region of the country in which there 
    was an increase in the number of employees covered by self-insured or 
    partially self-insured (reflecting the lower penetration of HMOs in 
    Southern states). Data about individual states do not appear to be 
    available. A recent GAO report notes that ``no analysis exists on the 
    number of individuals affected by these state [insurance] reforms'' 
    (Health Insurance Portability: Reform Could Ensure Continued Coverage 
    for Up to 25 Million Americans, HEHS-95-257, September 1995).
        For 1995, the South (stretching, under the Liston-Patterson 
    definition, from the South Atlantic states to the West South Central 
    states of Arkansas, Louisiana, Oklahoma and Texas) had 35% of all 
    employees covered by self-insured or partially self-insured plans, 
    while those same states had 30% of the private-sector employees with 
    health care coverage. Three of the seven states that had no pre-
    existing condition limitations regulations in the PWBA analysis were 
    Southern states; of the 11 states that had no guaranteed renewal 
    provisions for group health plans, four were in Southern states. It 
    would appear then, that to the extent that practices in the ERISA small 
    group market in Southern states diverge significantly from HIPAA 
    provisions employers will have to adhere to, there are possible major 
    impacts of HIPAA in those markets.
    (4). The Individual Insurance Market
        In the individual insurance market the statute provides for 
    guaranteed issue of a policy to ``eligible individuals'' (individuals 
    coming from the group market, who have 18 months of aggregate 
    creditable coverage, from any of various types of health care 
    coverage). In addition to this guaranteed issue requirement, insurers 
    are not permitted to apply any per-existing condition exclusions to 
    this group. Individual policies are guaranteed renewable except under 
    certain circumstances. The statute does not place any limits on the 
    premiums insurers may charge for the policies made available to 
    eligible individuals. States are permitted to have alternative 
    mechanisms that achieve the same ends as the HIPAA requirements, though 
    any alternative is required to have no pre-existing condition 
    exclusions.
        The individual insurance market reforms are of greatest benefit to 
    individuals who voluntarily or involuntarily leave their jobs and wish 
    to maintain some level of health insurance. As discussed above, the 
    availability of individual insurance may decrease ``job lock'' by 
    allowing people to maintain continuous protection as they move between 
    jobs. Individuals who enter the individual market from the group market 
    may choose to do so because their new employer may not offer insurance 
    or the employer's coverage is limited; or they may expect to be without 
    a job for a period of time (for example, because they are ``early 
    retirees'' who do not yet have Medicare entitlement and do not have 
    employment-based retiree health care coverage). The CBO projects, in 
    data cited above, that the number of people benefiting from the HIPAA 
    (getting coverage when it would have been denied absent HIPAA) 
    individual market reforms would ``plateau'' at the 150,000 range by the 
    fourth year of the law. The GAO (HEHS-95-257, cited above) determined 
    that about two million people each year could convert to individual 
    insurance from group coverage, based on turnover rates among small 
    employers and rates of COBRA continuation of coverage.
        Individual market premium effects vary by state. In state 
    regulatory activity, fewer states have provisions similar to HIPAA's in 
    the individual market as compared to state reforms in the small group 
    market. HIPAA will affect the individual insurance markets in many 
    states. The RAND and IHPP data indicate that only eleven states have 
    guaranteed issue laws for the individual market. Eight additional 
    states have an insurer (Blue Cross-Blue Shield) offering open 
    enrollment in the individual market. Twenty-three states have laws 
    limiting the period of pre-existing condition exclusions, but only one 
    state allows no such exclusion period, with most states allowing a 12-
    month exclusion period with a 6- or 12-month ``look back.''
        One of the most contentious issues in discussions of HIPAA's effect 
    on the individual insurance market has been the issue of premiums in 
    that market. HIPAA does not impose any rating requirements on insurers 
    in the
    
    [[Page 16916]]
    
    individual market, meaning that the insurers are free to price their 
    individual products in any manner that is consistent with state law. 
    IHPP data show that for the individual market, seven states have rating 
    bands (premiums must be within certain upper and lower bounds in 
    relation to a ``standard'' premium), and eight states require community 
    rating of some form (a form of rating that can be roughly described as 
    rating across a larger pool of insured individuals, for example, across 
    all of an issuer's insured individuals, across defined age categories, 
    etc.). Rating bands and community rating requirements have the same 
    intended effect as HIPAA, to increase the availability of insurance, 
    but they additionally seek to assure affordable coverage. There will be 
    interactions between the HIPAA approach to increased availability 
    (guaranteed issue and elimination of pre-existing condition exclusions 
    for certain individuals with prior coverage) and the rating approach in 
    those states in which guaranteed issue rules and pre-existing condition 
    exclusion rules differ from HIPAA's provisions.
        Affordability of individual coverage is a significant issue with 
    HIPAA. The Health Insurance Association of America (HIAA) has projected 
    that the individual market reform provisions of HIPAA will cause an 
    eventual 22% increase in premiums in that market (``The Cost of Ending 
    `Job Lock' or How Much Would Health Insurance Costs Go Up If 
    `Portability' of Health Insurance Were Guaranteed?'', February 20, 
    1996). HIAA projects, on that basis, that eventually 500,000 to one 
    million people would leave the individual insurance market because of 
    rate increases necessitated by the HIPAA reforms. HIAA bases this 
    estimate on the current number of people insured in the individual 
    market, the number of new entrants in the market, their costs, and the 
    price-sensitivity of purchasers of insurance.
        Other studies have arrived at conclusions that are very different 
    from the HIAA conclusions. The main difference with other studies is 
    that HIAA assumes that HIPAA will cause states to impose restrictions 
    on the level of premiums insurers may charge in the individual market. 
    There are no such requirements in HIPAA. The HIAA assumes that people 
    currently covered in the individual market will be included in the 
    rating pool that includes individuals who are newly insured under HIPAA 
    provisions. The American Academy of Actuaries (AAA), for example, found 
    that the premium increases in the individual market would be in the 
    range of two to five percent, and the increases would take effect over 
    a longer time span that one year. The AAA took into account current 
    state laws, including state laws related rate restrictions in the small 
    group market.
        Jacob Klerman, or RAND, examined HIAA's assumptions and methodology 
    and found that (a) using HIAA's assumptions, but employing more up-to-
    date or otherwise improved data (``better estimates of the underlying 
    figures''), the increase in individual premiums would be 5.7%; and (b) 
    using different assumptions, the premium effect would be 2.3% and may 
    be as little as 1% or less (New Estimates of the Effect of Kassebaum-
    Kennedy's Group-to-Individual Conversion Provision on Premiums for 
    Individual Health Insurance, RAND, 1996). For the latter projections, 
    Klerman assumed a different level of claims costs for new entrants 
    (150%, based on studies of the costs for COBRA continuation policies, 
    versus the HIAA's 200%), that the premium pricing for the new policies 
    would not be pooled with others in the individual market, and that 
    state laws would have effects that the HIAA analysis did not consider. 
    Note that, as with the GAO report quoted above, these analyses are 
    based on an earlier version of an insurance reform bill, S. 1028, in 
    which the guaranteed issue was available only to those with 18 months 
    of group coverage. This analysis does not measure how many more people 
    are encompassed in the larger HIPAA ``eligible individual'' group 
    comprising individuals whose last type of coverage was group coverage 
    but who had prior coverage during the 18-month period from a different 
    source; this will slightly increase the cost.
        Another study, done for HHS, by Actuarial Research Corporation 
    (ARC), had results that were similar to the RAND results. ARC projects 
    possible increases in individual premiums ranging from 1.4 percent to 
    2.8 percent.
    
    K. Statutory Provisions Affecting Administrative Processes
    
        While these rules implement the statute's goal of expanding 
    coverage and portability of coverage by reducing the use of pre-
    existing condition exclusions, for purposes of performing this economic 
    impact analysis, it is appropriate to break the regulations down into 
    the following components: certifications and notices informing 
    individuals of their right to request a certification; notification of 
    the application of a pre-existing condition exclusion period; 
    alternative methods of crediting coverage; and guidelines for 
    implementing the statue's special enrollment requirements. The notice 
    and notification requirements are largely a result of this rulemaking. 
    The certification requirements are largely prescribed by HIPAA, with 
    certain aspects that mitigate the impact of the statute resulting from 
    this rulemaking. While the alternative method of counting compliance is 
    authorized by HIPAA, the classes and categories of coverage to be 
    measured were created at the discretion of the three Departments.
    
    1. Staggered Effective Dates
    
        In general, the effective dates of HIPAA's group health plan 
    provisions are tied to plans' fiscal years and to the expiration of 
    collective bargaining agreements under which some plans are maintained. 
    Provisions whose effective dates are so tied included those pertaining 
    to pre-existing condition exclusions, crediting prior coverage, and 
    special enrollments. (The effective dates of HIPAA's certification 
    provisions are not so tied.) Non-collectively bargained plans become 
    subject to these provisions of HIPAA in the first plan year beginning 
    on or after the July 1, 1997. Collectively bargained plans become 
    subject the first plan year beginning on or after the later of July 1, 
    1997 or the expiration of a collective bargaining agreement that was in 
    place prior to HIPAA's date of enactment, August 21, 1996.
        More than one-half of plans begin their fiscal years on January 1. 
    Therefore, there is a large concentration of plans and participants 
    that become subject to HIPAA in January 1998. Overall, the proportions 
    of participants and plans (respectively) that become subject to HIPAA 
    in 1997 are 15 percent and 24 percent; in 1998, 68 percent and 69 
    percent; in 1999, 11 percent and 4 percent; and in 2000, 5 percent and 
    2 percent.
        The compliance costs of these regulations regarding certification 
    and notice, pre-existing condition exclusion notification, and notice 
    of enrollment rights was estimated based upon information in the public 
    domain and data available to the Departments on industry practices. To 
    derive data on health coverage and employment shifts of individuals, 
    for the purposes of this analysis the Departments referred to data 
    collected from the Census Bureau's Current Population Survey and Survey 
    of Income and Program Participation, as well as the National Health 
    Interview Survey and the Department of Labor's database of 1993 Form 
    5500 information, the most current available. Supplemental data on 
    employer-sponsored health care was obtained
    
    [[Page 16917]]
    
    from the Peat Marwick Benefits Survey and the BLS Employee Benefits 
    Survey.
    
    2. Initial vs. Ongoing Costs
    
        Costs may be separated into initial costs and ongoing costs. 
    Initial costs of the new certification, notice, pre-existing condition 
    exclusion notification, and special enrollment requirements have 
    several components, including capital costs of preparations for 
    collecting information such as purchasing or upgrading computers and 
    software, and record storage facilities. Initial costs may also be 
    expected to include programming or reprogramming automated systems to 
    track periods of prior creditable coverage, and to track plan 
    participants and the type of coverage they hold, e.g. individual or 
    family coverage. Initial costs also include up-front expenditures for 
    revisions of plan documents to comply with the new statutory and 
    regulatory requirements. These costs were annualized over the estimated 
    ``life'' of the regulation, 10 years, in order to show such costs on an 
    annual basis. It is estimated that the 15,604 plans that will process 
    certifications internally (rather than use a service provider) will 
    incur an average cost of $5,000 per plan to revise their automated 
    records systems to accommodate this information for a total cost of $78 
    million over 10 years beginning in 1997. Presented here as direct 
    costs, initial costs are a component of overall social costs.
        Ongoing expenditures incurred annually include the costs to group 
    health plans, health insurance issuers and self-funded plans of 
    performing the continuing administrative tasks of calculating periods 
    of creditable coverage, printing forms for notices, preparing an 
    original and a copy of notices and certifications for participants with 
    dependants having identical coverage, and mailing these documents to 
    individuals. Also included in ongoing expenditures is the cost to plans 
    which use pre-existing condition exclusions to notify participants of 
    the plans' provisions, and calculating periods of pre-existing 
    condition exclusions for new participants, and issuing an 
    individualized notification, as necessary, to each individual who would 
    be subject to a pre-existing condition exclusion of any duration. Total 
    annualized initial costs and ongoing costs were aggregated to estimate 
    total annual costs.
    
    3. The Certification Process
    
        The statute specifies that every individual leaving a group health 
    plan, ending COBRA coverage, ending individual insurance coverage, or 
    leaving other types of health coverage must receive a written 
    certification of creditable coverage containing specific information 
    about the individual and his or her coverage, including information on 
    the coverage of dependents. This requirement constitutes a burden in 
    information collection and processing.
        Despite recent incremental state reforms in the laws affecting the 
    group health insurance market, no states have required group health 
    plans or health insurance issuers to provide participants and their 
    dependents with certifications or notices regarding prior health 
    coverage. Therefore, the statute imposes discrete new burdens on all 
    group health plans and health insurance issuers in connection with 
    providing certifications, and issuing to individuals of their right to 
    receive a certification.
        Respondents preparing certification forms must collect the 
    appropriate information about a person, prepare a certification form, 
    and, in most cases, mail the information. One certification can serve 
    to provide information about dependents covered under the same policy. 
    The respondent may have to prepare multiple certification forms for an 
    individual, or for dependents, in the event that the certificate is 
    lost or misplaced. The process may require the development of new 
    information systems or, more likely, modifications to existing 
    information systems, to collect and process the necessary information.
        The statute makes the certification requirement a key 
    implementation component of the portability provision in both the group 
    and individual markets.
        The cost of providing certifications for private group plans 
    (absent the regulatory relief described below) is estimated to be at 
    least $98 million for 69 million certifications in 1997 and $84 million 
    for 59 million in each subsequent year. Absent transition relief 
    provided under the regulations, early year costs could be far higher. 
    The direct cost of certifications contributes to the overall social 
    cost of the statute.
    
    L. Impact of Regulatory Discretion
    
        These regulations mitigate the impact of the statutory requirements 
    on the regulated public, while preserving protections, in several ways. 
    These regulations will reduce implementation costs.
        The Departments exercised discretion in connection with group plan 
    provisions, as follows:
        First, intermediate issuers will not have to issue a certification 
    when an individual changes options under the same health plan. In lieu 
    of the certification, they could simply transfer the start and stop 
    dates of coverage to the plan. An individual would retain the right to 
    get a certification upon request if they leave the plan.
        Second, telephonic certification will fulfill the requirement to 
    sent a certification if the receiving plan and the prior plan mutually 
    agree to that arrangement. The individual can always get a written 
    certification upon request.
        Third, the requirement to send certifications on June 1, 1997 to 
    those who have left plans between October 1, 1996 and May 31, 1997 can 
    be satisfied by sending a notice; the Departments have offered a model 
    notice in these regulations for that purpose.
        Fourth, until July 1, 1998, plans and issuers that do not collect 
    individual information on dependants can comply with the requirement to 
    send each dependant a separate certification by simply listing the 
    category of coverage (e.g., individual, spouse or family).
        Fifth, in situations where the issuer and the plan contract for the 
    issuer to complete the certifications, the plan would not remain liable 
    if the issuer failed to send the certifications.
        Thus, plans would not need to keep data and files on this 
    information.
        Sixth, the period of coverage listed on automatic certifications 
    will only be the last continuous period of coverage without any break. 
    This is the most efficient and simplest method of record keeping for 
    plans and issuers.
        Seventh, the period of coverage contained in the on-request 
    certification will be all periods of coverage ending within 24 months 
    before the date of the request. Essentially, a plan may simply look 
    back two years and send copies of any automatic certifications issued 
    during that period.
        The above reductions in burdens on plans and issuers may cause more 
    frequent circumstances in which participants are required to prove 
    creditable coverage and the status of their dependants. In order to 
    help offset some of the additional burdens that will be shifted to the 
    participants, the regulations provide the following protections:
        First, if an individual is required to demonstrate dependent 
    status, the group health plan or issuer is required to treat the 
    individual as having furnished a certificate showing the dependent 
    status if the individual attests to such dependency and the period of 
    such status, and the individual cooperates with the plan's or issuer's 
    efforts to verify the dependent status.
    
    [[Page 16918]]
    
        Second, a plan shall treat an individual as having furnished a 
    certificate if the individual attests to the period of creditable 
    coverage, and the individual also presents relevant corroborating 
    evidence of some creditable coverage during the period and the 
    individual cooperates with the plan's efforts to verify the 
    individual's coverage.
        Third, plans and issuers that impose preexisting condition 
    exclusions periods must notify participants of this fact. They must 
    also explain that prior creditable coverage can reduce the length of a 
    preexisting condition exclusion period and offer to request a 
    certification on the participant's behalf. An exclusion may not be 
    imposed until this notice is given. This is beneficial to participants 
    insofar as it forewarns them of potential claim denials and enables 
    them to more easily exercise their right to protection from such 
    denials under HIPAA's portabliity provisions.
        Fourth, a plan that imposes a preexisting condition exclusion must 
    notify a participant if the individual's creditable coverage is not 
    enough to completely offset the exclusion period, and give the 
    individual the option to provide additional information. An exclusion 
    may not be imposed until this notice is given. This provides 
    participants an opportunity to correct any failure to establish credit 
    for prior coverage before a claim is denied.
        Under the regulation, in the group health plan enrollment materials 
    ordinarily provided to most new participants, plans that contain pre-
    existing condition exclusion provisions must also provide notice that 
    the plan contains these provisions, that the participant has the right 
    to prove prior creditable coverage, including the right to secure a 
    certificate from a prior plan or issuer, and that the new plan will 
    assist in obtaining the certificate. Those plans using the alternative 
    method of crediting coverage also must disclose their methods to the 
    participant, including an identification of the categories of coverage 
    used.
        In addition, a plan seeking to impose a pre-existing condition 
    exclusion on a participant or dependant must inform them in writing of 
    the determination that they lack adequate prior coverage, and provide 
    an opportunity for the individual to submit additional materials 
    regarding prior creditable coverage, and provide an explanation of any 
    appeals procedure.
        The annual cost of these disclosure procedures to private group 
    plans is estimated to be $280,000 in 1997, $2.1 million in 1998, and 
    $1.9 million in 1999 (about 20 cents per notice). The same costs for 
    state group plans would be $25,500, $51,000, and $51,000, respectively. 
    For local plans, they would be $42,000, $84,000, and $84,000. The 
    Departments believe the marginal burden of the notice will be modest 
    because, irrespective of the notice requirement, under the statute 
    plans must make this determination before imposing a preexisting 
    condition exclusion. Comments are encouraged as to whether this 
    assumption is appropriate. These costs do not include any burdens 
    attributable to the use of the alternative method of crediting 
    coverage, since it is assumed that any plans incorporating this method 
    will do so only if the net cost is less than using the standard method. 
    Under the alternative method of crediting coverage, the regulation 
    allows the prior plan to charge the receiving plan using the 
    alternative method for the reasonable costs of providing evidence of 
    classes and categories of prior health coverage.
        On balance, to the extent that the Departments have exercised 
    regulatory discretion, they have acted to reduce compliance costs. This 
    is particulary true with respect to the certification process.
        These regulations attempt to reduce the burden of certifications by 
    limiting the amount of information that needs to be reported and 
    offering a model form that can be used to satisfy the requirement of 
    the law. In the absence of a written certification, the regulations 
    allow for alternative means of establishing creditable coverage, which 
    includes having the individual present documentation of coverage or 
    conducting telephone verification with the entity that previously 
    covered the individual.
        During a transition period, respondents may provide individuals 
    with a notice that they have the right to receive a certificate of 
    creditable coverage, a requirement that can be met by including the 
    information in an evidence of coverage or other generic document 
    individuals receive that contains information about their policy. This 
    notice may be provided in lieu of a certificate for events that occur 
    on or after October 1, 1996 but before June 1, 1997.
        The cost to issuers of the certification requirement is primarily 
    in the paperwork production of the certification form. All health 
    insurance issuers are likely to have the kinds of systems in place to 
    be able to produce the information necessary for a certification, 
    although there will be moderate systems start-up costs, and some 
    systems modifications for insurers and HMOs. Systems modifications may 
    also be necessary to retain the data for the certificates for several 
    years, but, like the other requirements, this burden should also be 
    limited. The model certification form of the Preamble contains the kind 
    of information that is routinely used as the basis for claims 
    processing by a health insurance issuer or by an HMO (for example, in 
    adjudicating an out-of-network claim).
        For example, in order to deny a claim dating from a period prior to 
    the beginning date of coverage of a particular individual, the issuer's 
    information system could determine that (1) a particular individual was 
    covered by the issuer; (2) the issuer identification number submitted 
    with the claim is correct; (3) the individual was insured on the date 
    the health care service was provided; (4) the service was provided 
    during a waiting period or affiliation period before coverage was 
    available; and (5) coverage may have ended prior to the date of 
    service. The issuer's information system would also determine the 
    limitations of coverage (e.g. high or low option coverage, with or 
    without specific riders). The remaining information of the 
    certification form could also be available to the issuer, especially 
    for COBRA-eligible individuals: whether COBRA continuation coverage is 
    involved (given that the premium is charged directly to the individual 
    at a specified rate); the beginning and ending dates of coverage and 
    waiting periods; and the name, address, phone number and contact person 
    (or Department) for information.
        Respondents may need to modify their systems to determine whether, 
    for a given insurer's coverage of a particular individual, there was a 
    63-day period of interrupted coverage for purposes of specifying this 
    information on a certification form. As noted above, the Departments 
    have taken into consideration the difficulties insurers have in 
    identifying dependents under family coverage, and the regulations make 
    appropriate accommodations, in recognition of the need for a transition 
    period during which information about dependent coverage information 
    may be unavailable from issuers.
        The cost of producing and issuing certifications (or notices in 
    lieu of certifications where permitted) for private group plans is 
    estimated to be $57 million for 53 million certifications in 1997, $64 
    million for 44 million in 1998, and $66 million for 44 million in each 
    subsequent year. Medicaid programs would provide 10 million 
    certifications annually at an annual cost of $600,000. Medicare would 
    issue
    
    [[Page 16919]]
    
    92,000 annually at a cost of $115,000. (Should HHS decide to allow the 
    Medicare award and termination letters to suffice as certifications, 
    then there would be no cost to the Medicare program for the HIPAA 
    certification requirements.) By 1999, the annual cost and volume would 
    total $500,000 and 200,000 for OPM, $2.9 million and 1.9 million for 
    state plans, and $6.1 million and 4.1 million for local plans, and $4.7 
    million and 2.9 million for individual market issuers.
        Relative to the cost implied by the statute alone, regulatory 
    provisions directed at the certification process reduce private group 
    plans' cost of compliance by a minimum of $41 million (or 42 percent) 
    in 1997, $20 million (or 24 percent) in 1998, and $18 million (or 21 
    percent) in 1999 and later years, through the creation of transitional 
    rules, safe harbors and good faith compliance periods. The regulation 
    acts to reduce parallel burdens on issuers and state and local 
    government group plans in similar proportion.
        In another discretionary provision, these regulations require group 
    plans to notify eligible new employees of their special enrollment 
    rights. This provision is necessary to make sure employees are 
    sufficiently informed to exercise their rights within the 30-day window 
    provided in the statute. The cost of this disclosure is expected to be 
    small, since it is a uniform disclosure that can accompany ordinary 
    materials provided to new participants. In order to minimize the 
    burden, the preamble to these regulations provides model language for 
    the notice adequate for meeting the statutory obligation. The cost, 
    which would reach $1.72 million in 1999 for private group plans, is 
    described in the PRA analysis. In 1999, the cost for State plans would 
    reach $167,000; the cost for local plans would reach $290,000.
        The direct cost of certifications and notices contribute to the 
    overall social cost of the statute and regulations.
        HHS has exercised regulatory discretion regarding two specific 
    provisions that will be enforced exclusively by HHS (also referred to 
    as the ``non-shared group market'' provisions).
        These two areas are as follows:
    Guaranteed Availability of Coverage for Employers in the PHS Act Group 
    Health Market Provisions
        The group market provisions include rules relating to guaranteed 
    availability of coverage for employers in the small group market that 
    are only in the PHS Act (not in ERISA or the Code). Section 146.150 of 
    the HHS regulations implements section 2711 of the PHS Act. In general, 
    this section requires health insurance issuers that offer coverage in 
    the small group market to offer all policy forms to any eligible small 
    employer and to accept for enrollment every eligible individual without 
    regard to health status. HHS has interpreted this guaranteed 
    availability requirement to apply to all products offered in the small 
    group market. Some States and issuers argue that the statute would 
    permit guaranteed availability of an issuer's basic and standard plan, 
    as opposed to all products offered by the issuer in the small group 
    market. HHS does not agree with this interpretation and have proposed 
    our interpretation in the regulation. Depending upon State law, this 
    decision may provide the benefit of additional choices to small 
    employers purchasing coverage in the small group market, while adding 
    some potential costs for issuers offering coverage in the small group 
    market.
    Exclusion of Certain Plans From the PHS Act Group Market Requirements
        The group market provisions also include rules under which certain 
    plans are excluded from the group market provisions that are only in 
    the PHS Act (not in ERISA or the Code). Section 146.180 of the HHS 
    regulations implements section 2721 of the PHS Act. Section 146.180(b) 
    includes rules pertaining to non-federal governmental plans, which are 
    permitted under HIPAA to elect to be exempted from some or all of 
    HIPAA's requirements in the PHS Act. HHS has exercised regulatory 
    discretion by prescribing the form and manner of the election and the 
    contents of the notice. HHS has also required a non-federal 
    governmental plan making this election to notify plan participants, at 
    the time of enrollment and on an annual basis, of the fact and 
    consequences of the election. HHS has exercised this regulatory 
    authority in order to ensure adequate documentation of a non-federal 
    governmental plan's proper and appropriate election without placing an 
    undue burden on the plan. In addition, HHS has provided a non-federal 
    governmental plan the flexibility to elect to opt out of specific 
    provisions of the statute and have allowed for this flexibility in the 
    contents of the notice. The cost of providing these notices for non-
    federal governmental would range from $79,000 to $158,000 in 1997 and 
    from $158,000 to $315,000 in 1999.
        HHS has also exercised regulatory discretion in connection with 
    individual market provisions by specifying that college health plans 
    are treated as bona fide associations. Since, under HIPAA, coverage 
    offered through a bona fide association is creditable coverage, 
    individuals covered under a college plan would receive credit for this 
    coverage. However, because this coverage is offered though a bona fide 
    association (as defined in Part 144 of the group market rules), the 
    issuer benefits because it does not have to make the coverage available 
    in the individual market to eligible individuals, and does not have to 
    renew coverage for a student who leaves the association. This 
    regulatory provision is expected to minimally disrupt business 
    practices for those college plans.
        HHS also exercised regulatory discretion in connection with 
    individual market provisions. When an eligible individual applies for 
    coverage in the individual market, the effective date of such coverage 
    is deemed, in the regulations, to be the date on which the individual 
    applies for such coverage, and assuming the individual's application 
    for coverage was accepted.
        The impact of this regulatory provision is that an individual who 
    wishes to maintain creditable coverage may delay, for up to 63 days, an 
    application for coverage in the individual insurance market, especially 
    if he or she is assured of being covered by an issuer (e.g., if the 
    person is guaranteed issuance of an individual product as an individual 
    coming from group coverage, under the Act's guaranteed availability 
    provisions). The individual may forego medical treatment during the 63-
    day period of non-coverage, resulting in a deterioration of health on 
    entering the new health plan, with a potential for greater costs 
    incurred by the insurer or health plan.
        The regulation could have required that the individual apply for 
    coverage within a reasonable time period in advance of the 63-day 
    period, such as 30 days after the end of prior coverage (which is 
    similar to the statutory requirement for a request for enrollment in a 
    group health plan following exhaustion of COBRA coverage or other 
    exhaustion of coverage); or, the insurer could have been required to 
    begin coverage within some specified time period after application. 
    However, the approach taken in the regulation is consistent with 
    statutory provisions regarding the treatment of waiting periods or HMO 
    affiliation periods, which the statute specifically excludes from being 
    considered breaks in coverage. The regulatory provision also accords 
    the same status to all individuals in any circumstance by making a 63-
    day period the maximum during which an individual can be
    
    [[Page 16920]]
    
    without coverage and still receive credit for creditable coverage.
    
    M. Paperwork Reduction Act--Department of Labor and Department of the 
    Treasury
    
        The Department of Labor and the Department of the Treasury have 
    submitted this emergency processing public information collection 
    request (ICR), consisting of three distinct ICRs, to the OBM for review 
    and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-
    13, 44 U.S.C. Chapter 35). The Departments have asked for OMB clearance 
    as soon as possible, and OMB approval is anticipated by or before June, 
    1, 1997.
        These regulations contain three distinct ICRs. Two of them 
    (Establishing Prior Creditable Coverage and Notice of Enrollment 
    Rights) are prescribed by the statute.
        The first ICR implements statutorily prescribed requirements 
    necessary to establish prior creditable coverage. This is accomplished 
    primarily through the issuance of certificates of prior coverage by 
    group health plans or by service providers that the group health plans 
    contract with in order to provide these documents. In addition, this 
    ICR permits the use of a notice that may be used by the plans to meet 
    their obligations in connection with periods of coverage ending during 
    the transition period, October 1, 1996 through May 31, 1997, saving the 
    respondents both hours and cost during that period. This ICR also 
    covers the requests that certain plans will make regarding additional 
    information they require because they are using the Alternative Method 
    of Crediting Coverage. Finally, this ICR also includes the occasional 
    circumstances where a participant is unable to secure a certificate and 
    needs to provide some supplemental form of documentation in order to 
    establish prior creditable coverage.
        The second ICR, Notice of Special Enrollment Rights, implements the 
    statutorily prescribed disclosure obligation of the plans to inform a 
    participant, at the time of enrollment, of the plan's special 
    enrollment rules.
        The third ICR, Notice of Pre-Existing Condition Exclusion, concerns 
    the disclosure requirements on those plans that contain pre-existing 
    condition exclusion provisions. This ICR has two components: a notice 
    to all participants at the time of enrollment stating the terms of the 
    plan's pre-exisiting condition provisions, the participant's right to 
    demonstrate creditable coverage, and that the plan or issuer will 
    assist in securing a certificate if necessary; and notice by the plan 
    of its determination that an exclusion period applies to an individual.
    
    1. Establishing Prior Creditable Coverage
    
    i. Department of Labor
        The Department of Labor, as part of its continuing effort to reduce 
    paperwork and respondent burden, conducts a preclearance consultation 
    program to provide the general public and federal agencies with an 
    opportunity to comment on proposed information collection requests 
    (ICR) in accordance with the Paperwork Reduction Act of 1995 (PRA 95) 
    (Pub. L. 104-13, 44 U.S.C. chapter 35) and 5 CFR 1320.11. This program 
    helps to ensure that requested data can be provided in the desired 
    format, reporting burden (time and financial resources) is minimized, 
    collection instruments are clearly understood, and the impact of 
    collection requirements on respondents can be properly assessed. 
    Currently, the Pension and Welfare Benefits Administration is 
    soliciting comments concerning the proposed new collection of 
    Establishing Prior Creditable Coverage.
        Dates: Written comments must be submitted to the office listed in 
    the addressee section below on or before May 31, 1997. In light of the 
    request for OMB clearance by June 1, 1997, submission of comments 
    within the first 30 days is encouraged to ensure their consideration.
        The Department of Labor is particularly interested in comments 
    which:
         evaluate whether the proposed collection is necessary for 
    the proper performance of the functions of the agency, including 
    whether the information will have practical utility;
         evaluate the accuracy of the agency's estimate of the 
    burden of the proposed collection of information, including the 
    validity of the methodology and assumptions used;
         enhance the quality, utility, and clarity of the 
    information to be collected; and
         minimize the burden of the collection of information on 
    those who are to respond, including through the use of appropriate 
    automated, electronic, mechanical, or other technological collection 
    techniques or other forms of information technology, e.g., permitting 
    electronic submissions of responses.
        Addressee: Gerald B. Lindrew, Office of Policy and Research, U.S. 
    Department of Labor, Pension and Welfare Benefits Administration, 200 
    Constitution Avenue, Room N-5647, Washington, DC 20210. Telephone: 202-
    219-4782 (this is not a toll-free number). Fax: 202-219-4745.
    ii. Department of the Treasury
        The collection of information is in Section 54.9801-5T. This 
    information is required by the statute so that participants will be 
    informed about their rights under HIPAA and about the amount of 
    creditable coverage that they have accrued under a group health plan. 
    The likely respondents are business or other for-profit institutions, 
    non-profit institutions, small businesses or organizations, and Taft-
    Hartley trusts. Responses to this collection of information are 
    mandatory.
        Books or records relating to a collection of information must be 
    retained as long as their contents may be come material in the 
    administration of any internal revenue law. Generally, tax returns and 
    tax return information are confidential, as required by 26 U.S.C. 6103.
        Comments on the collection of information should be sent to the 
    Office of Management and Budget, Attn: Desk Officer for the Department 
    of the Treasury, Office of Information and Regulatory Affairs, 
    Washington, DC 20503, with copies to the Internal Revenue Service, 
    Attn: IRS Reports Clearance Officer, T:FP, Washington, DC 20224. 
    Comments on the collection of information should be received by May 31, 
    1997. In light of the request for OMB clearance by June 1, 1997, 
    submission of comments within the first 30 days is encouraged to ensure 
    their consideration. Comments are specifically requested concerning:
        Whether the proposed collection of information is necessary for the 
    proper performance of the functions of the Internal Revenue Service, 
    including whether the information will have practical utility;
        The accuracy of the estimated burden associated with the proposed 
    collection of information;
        How to enhance the quality, utility, and clarity of the information 
    to be collected;
        How to minimize the burden of complying with the proposed 
    collection of information, including the application of automated 
    collection techniques or other forms of information technology; and
        Estimates of capital or start up costs and costs of operation, 
    maintenance, and purchase of services to provide information.
        Additonal PRA 95 Information:
        I. Background: In order to meet HIPAA's goal of improving access to 
    and portability of health care benefits,
    
    [[Page 16921]]
    
    the statute provides that, after the submission of evidence 
    establishing prior creditable coverage, a subsequent health insurance 
    provider would be limited in the extent to which it could use pre-
    existing condition exclusions to limit coverage. This ICR covers the 
    submission of materials sufficient to establish prior creditable 
    coverage.
        II. Current Actions: Under 29 CFR 2590.701-5 and 26 CFR 54.9801-5T 
    of the interim rule, a group health plan offering group health 
    insurance coverage is obligated to provide a written certificate of 
    information suitable for establishing the prior creditable coverage of 
    a participant or beneficiary. To the extent that a certification is not 
    available or inadequate to prove prior creditable coverage, paragraph 
    (c) provides other methods for establishing creditable coverage. During 
    the transition period for certification (29 CFR 2590.710(e) and 26 CFR 
    54.9806-1T(e)), plans have the option of providing notices regarding 
    participant's rights to certification rather than the certification 
    itself; plans then provide certificates only to those participants who 
    request them. 29 CFR 2590.701-5(a)(7) and 26 CFR 54.9801-5T(a)(7) 
    provides special rules for establishing prior coverage of defendants, 
    and 29 CFR 2590.701-5(b) and 26 CFR 54.9801-5T(b) provides guidance on 
    providing evidence of coverage to those plans that use the alternative 
    method of crediting coverage.
        These regulations offer model certification and notice forms to be 
    used by group health plans and health insurance issuers, containing the 
    minimum information mandated by the statute. Based on past experience, 
    the staff believes that most of the materials required to be exchanged 
    under the certification procedure will be prepared by contract service 
    providers such as insurance companies and third-party administrators.
        Type of Review: New
        Agencies: U.S. Department of Labor, Pension and Welfare Benefits 
    Administration; U.S. Department of the Treasury, Internal Revenue 
    Service.
        Title: Establishing Prior Creditable Coverage
        Affected Public: Individuals or households; Business or other for-
    profit; Not-for-profit institutions; Group Health Plans.
        Frequency: On occasion
        Burden:
    
    ----------------------------------------------------------------------------------------------------------------
                                                                       Average time                                 
                                           Total           Total       per  response   Burden hours                 
                  Year                  respondents      responses        (range)         (range)      Cost (range) 
                                                                         (minutes)                                  
    ----------------------------------------------------------------------------------------------------------------
    1997............................       2,600,000      51,799,410            3.23         502,080     $57,180,000
                                      ..............  ..............            6.12         950,710      84,590,000
    1998............................       2,600,000      44,431,970            5.04         672,120      64,480,000
                                      ..............  ..............           11.77       1,569,390     119,310,000
    1999............................       2,600,000      44,399,150            5.27         702,360      66,310,000
                                      ..............  ..............           12.01       1,599,630     121,140,000
                                     -------------------------------------------------------------------------------
          Totals....................  ..............  ..............  ..............  ..............  ..............
    ----------------------------------------------------------------------------------------------------------------
    
        Start up costs: It is estimated that the 15,604 plans that will 
    perform these functions internally (rather than use a service provider) 
    will incur an average cost of $5,000 per plan to revise their automated 
    records systems to accommodate this information for a total cost of $78 
    million over 10 years beginning in 1997.
        Estimated total cost:
        Comments submitted in response to this notice will be summarized 
    and/or included in the request for Office of Management and Budget 
    approval of the information collection request; they will also become a 
    matter of public record.
    
    2. Notice of Enrollment Rights
    
    i. Department of Labor
        The Department of Labor, as part of its continuing effort to reduce 
    paperwork and respondent burden, conducts a preclearance consultation 
    program to provide the general public and federal agencies with an 
    opportunity to comment on proposed information collection requests 
    (ICR) in accordance with the Paperwork Reduction Act of 1995 (PRA 95) 
    (Pub. L. 104-13, 44 U.S.C. Chapter 35) and 5 CFR 1320.11. This program 
    helps to ensure that requested data can be provided in the desired 
    format, reporting burden (time and financial resources) is minimized, 
    collection instruments are clearly understood, and the impact of 
    collection requirements on respondents can be properly assessed. 
    Currently, the Pension and Welfare Benefits Administration is 
    soliciting comments concerning the proposed new collection of Notice of 
    Enrollment Rights.
        Dates: Written comments must be submitted to the office listed in 
    the addressee section below on or before May 31, 1997. In light of the 
    request for OMB clearance by June 1, 1997, submission of comments 
    within the first 30 days is encouraged to ensure their consideration.
        The Department of Labor is particularly interested in comments 
    which:
         evaluate whether the proposed collection is necessary for 
    the proper performance of the functions of the agency, including 
    whether the information will have practical utility;
         evaluate the accuracy of the agency's estimate of the 
    burden of the proposed collection of information, including the 
    validity of the methodology and assumptions used;
         enhance the quality, utility, and clarity of the 
    information to be collected; and
         minimize the burden of the collection of information on 
    those who are to respond, including through the use of appropriate 
    automated, electronic, mechanical, or other technological collection 
    techniques or other forms of information technology, e.g., permitting 
    electronic submissions of responses.
        Addressee: Gerald B. Lindrew, Office of Policy and Research, U.S. 
    Department of Labor, Pension and Welfare Benefits Administration, 200 
    Constitution Avenue, Room N-5647, Washington, D.C. 20210. Telephone: 
    202-219-4782 (this is not a toll-free number). Fax: 202-219-4745.
    ii. Department of the Treasury
        The collection of information is in Section 54.9801-6T. This 
    information is required by the statute so that participants will be 
    informed about their rights under HIPAA and about the amount of 
    creditable coverage that they have accrued under a group health plan.
    
    [[Page 16922]]
    
    The likely respondents are business or other for-profit institutions, 
    non-profit institutions, small businesses or organizations, and Taft-
    Hartly trusts. Responses to this collection of information are 
    mandatory.
        Books or records relating to a collection of information must be 
    retained as long as their contents may become material in the 
    administration of any internal revenue law. Generally, tax returns and 
    tax return information are confidential, as required by 26 U.S.C. 6103.
        Comments on the collection of information should be sent to the 
    Office of Management and Budget, Attn: Desk Officer for the Department 
    of the Treasury, Office of Information and Regulatory Affairs, 
    Washington, DC 20503, with copies to the Internal Revenue Service, 
    Attn: IRS Reports Clearance Officer, T:FP, Washington, DC 20224. 
    Comments on the collection of information should be received by May 31, 
    1997. In light of the request for OMB clearance by June 1, 1997, 
    submission of comments within the first 30 days is encouraged to ensure 
    their consideration. Comments are specially requested concerning:
        Whether the proposed collection of information is necessary for the 
    proper performance of the functions of the Internal Revenue Service, 
    including whether the information will have practical utility;
        The accuracy of the estimated burden associated with the proposed 
    collection of information;
        How to enhance the quality, utility, and clarity of the information 
    to be collected;
        How to minimize the burden of complying with the proposed 
    collection of information, including the application of automated 
    collection techniques or other forms of information technology; and
        Estimates of capital or start up costs and costs of operation, 
    maintenance, and purchase of services to provide information.
        Additional PRA 95 Information:
        I. Background: In order to improve participants' understanding of 
    their rights under an employer's welfare benefits plan, the statute 
    provides that, a participant be provided with a description of a plan's 
    special enrollment rules on or before the time when a participant is 
    offered the opportunity to enroll in a group health plan.
        II. Current Actions: Under 29 CFR 2590.701-6 and 26 CFR 54.9801-6T 
    of the interim rule, a group health plan offering group health 
    insurance coverage is obligated to provide a description of the plans' 
    special enrollment rules. The special enrollment rules generally apply 
    in circumstances when the participant initially declined to enroll in 
    the plan, and subsequently would like to have coverage.
        These regulations offer a model form to be used by group health 
    plans and health insurance issuers, containing the minimum information 
    mandated by the statute. Based on past experience, the staff believes 
    that most of the materials required to be supplied under this ICR will 
    be prepared by contract service providers such as insurance companies 
    and third-party administrators.
        Type of Review: New.
        Agencies: U.S. Department of Labor, Pension and Welfare Benefits 
    administration; U.S. Department of the Treasury, Internal Revenue 
    Service.
        Title: Notice of Enrollment Rights.
        Affected Public: Individuals or households; Business or other for-
    profit; Not-for-profit institutions; Group Health Plans.
        Frequency: On occasion.
        Burden:
    
    ----------------------------------------------------------------------------------------------------------------
                                        Total                       Average time per                                
                 Year                respondents        Total           response       Burden hours        Cost     
                                        (000)         responses        (minutes)                                    
    ----------------------------------------------------------------------------------------------------------------
    1997.........................       2,600,000         499,080  .50..............             750         100,000
    1998.........................       2,600,000       7,622.010  .50..............          11,430       1,460,000
    1999.........................       2,000,000       8,959,380  .50..............          13,440       1,720,000
                                  ----------------------------------------------------------------------------------
          Totals.................  ..............  ..............  .................  ..............  ..............
    ----------------------------------------------------------------------------------------------------------------
    
    3. Notice of Pre-Existing Condition Exclusion
    
    i. Department of Labor
        The Department of Labor, as part of its continuing effort to reduce 
    paperwork and respondent burden, conducts a preclearance consultation 
    program to provide the general public and federal agencies with an 
    opportunity to comment on proposed information collection requests 
    (ICR) in accordance with the Paperwork Reduction Act of 1995 (PRA 95) 
    (Pub. L. 104-13, 44 U.S.C. Chapter 35) and 5 CFR 1320.11. This program 
    helps to ensure that requested data can be provided in the desired 
    format, reporting burden (time and financial resources) is minimized, 
    collection instruments are clearly understood, and the impact of 
    collection requirements on respondents can be properly assessed. 
    Currently, the Pension and Welfare Benefits Administration is 
    soliciting comments concerning the proposed new collection of Notice of 
    Pre-Existing Condition Exclusion.
        Dates: Written comments must be submitted to the office listed in 
    the addressee section below on or before May 31, 1997. In light of the 
    request for OMB clearance by June 1, 1997, submission of comments 
    within the first 30 days is encouraged to ensure their consideration.
        The Department of Labor is particularly interested in comments 
    which:
         evaluate whether the proposed collection is necessary for 
    the proper performance of the functions of the agency, including 
    whether the information will have practical utility;
         evaluate the accuracy of the agency's estimate of the 
    burden of the proposed collection of information, including the 
    validity of the methodology and assumptions used;
         enhance, the quality, utility, and clarity of the 
    information to be collected; and
         minimize the burden of the collection of information on 
    those who are to respond, including through the use of appropriate 
    automated, electronic, mechanical, or other technological collection 
    techniques or other forms of information technology, e.g., permitting 
    electronic submissions of responses.
        Addressee: Gerald B. Lindrew, Office of Policy and Research, U.S. 
    Department of Labor, Pension and Welfare Benefits Administration, 200 
    Constitution Avenue, Room N-5647, Washington, D.C. 20210. Telephone: 
    202-219-4782 (this is not a toll-free number) Fax: 202-219-4745.
    
    [[Page 16923]]
    
    ii. Department of the Treasury
        The collection of information is in Sections 54.9801-3T, 54.9801-
    4T, and 54.9801-5T. This information is required by the statute so that 
    participants will be informed about their rights under HIPAA and about 
    the amount of creditable coverage that they have accrued under a group 
    health plan. The likely respondents are business or other for-profit 
    institutions, non-profit institutions, small businesses or 
    organizations, and Taft-Hartley trusts. Responses to this collection of 
    information are mandatory.
        Books or records relating to a collection of information must be 
    retained as long as their contents may become material in the 
    administration of any internal revenue law. Generally, tax returns and 
    tax return information are confidential, as required by 26 U.S.C. 6103.
        Comments on the collection of information should be sent to the 
    Office of Management and Budget, Attn: Desk Officer for the Department 
    of the Treasury, Officer of Information and Regulatory Affairs, 
    Washington, DC 20503, with copies to the Internal Revenue Service, 
    Attn: IRS Reports Clearance Officer, T:FP, Washington, DC 20224. 
    Comments on the collection of information should be received by May 31, 
    1997. In light of the request for OMB clearance by June 1, 1997, 
    submission of comments within the first 30 days in encouraged to ensure 
    their consideration. Comments are specifically requested concerning:
        Whether the proposed collection of information is necessary for the 
    proper performance of the functions of the Internal Revenue Service, 
    including whether the information will have practical utility;
        The accuracy of the estimated burden associated with the proposed 
    collection of information;
        How to enhance the quality, utility, and clarity of the information 
    to be collected;
        How to minimize the burden of complying with the proposed 
    collection of information, including the application of automated 
    collection techniques or other forms of information technology; and
        Estimates of capital or start up costs and costs of operation, 
    maintenance, and purchase of services to provide information.
        Additional PRA 95 Information:
        I. Background: In order to meet HIPAA's goal of improving 
    portability of health care coverage, participants needs to understand 
    their rights to show prior creditable coverage when entering a group 
    health plan that contain pre-existing condition exclusion provisions. 
    In addition, participants entering plans that use the alternative 
    method of crediting coverage also need to be informed of the plan's 
    provisions. Therefore, the Department has determined that plans that 
    contain these provisions must disclose that fact to new participants, 
    as well as inform individual participants of the extent to which a pre-
    existing condition exclusion applies to them.
        II. Current Actions: 29 CFR 2590.701-3(c) and 26 CFR 54.9801-3T(c) 
    requires that a group health plan or health insurance issuer offering 
    group health insurance under the plan may not impose any pre-existing 
    condition exclusions on a participant unless the participant has been 
    notified in writing that the plan contains per-existing condition 
    exclusions, that a participant has the right to demonstrate any period 
    of prior creditable coverage, and that the plan or issuer will assist 
    the participant in obtaining a certificate of prior coverage from any 
    prior plan or issuer, if necessary. 29 CFR 2590.701-4(c)(4) and 26 CFR 
    54.9801-4T(c)(4) requires that plans that use the alternative method of 
    crediting coverage disclose their method at the time of enrollment in 
    the plan. No additional cost of preparing or distributing this 
    information has been included in this analysis because plans would only 
    pursue this option if it were, on net, less costly than the standard 
    method.
        In addition, 29 CFR 2590.701-5(d)(2) and 26 CFR 54.9801-5T(d)(2) 
    requires that before a plan or issuer imposes a pre-existing condition 
    exclusion on a particular participant, it must first disclose that 
    determination in writing, including the basis for the decision, and an 
    explanation of any appeal procedure established by the plan or issuer.
        Type of Review: New.
        Agencies: U.S. Department of Labor, Pension and Welfare Benefits 
    Administration; U.S. Department of the Treasury, Internal Revenue 
    Service.
        Title: Notice of Pre-Existing Exclusion Provisions.
        Afffected Public: Individuals or households; Business or other for-
    profit; Not-for-profit institutions; Group Health Plans.
        Frequency: On occasion.
        Burden:
    
    ----------------------------------------------------------------------------------------------------------------
                                                                       Average time                                 
             Cite/reference                Total           Total      per  responses   Burden hours        Cost     
                                        respondents      responses       (minutes)                                  
    ----------------------------------------------------------------------------------------------------------------
    Notice at time of enrollment:                                                                                   
        1997........................       1,261,450         500,800            0.70           2,470        $180,000
        1998........................       1,261,450       7,626,880            0.54          16,300       1,700,000
        1999........................       1,261,450       8,959,700            0.50          13,750       1,730,000
    Notice of pre-existing condition                                                                                
     causing lack of coverage:                                                                                      
        1997........................       1,261,450          57,900            2.27           1,800         100,000
        1998........................       1,261,450         862,830            0.84           6,160         410,000
        1999........................       1,261,450       1,008,810            0.52           1,830         210,000
                                     -------------------------------------------------------------------------------
          Totals....................  ..............  ..............  ..............  ..............  ..............
    ----------------------------------------------------------------------------------------------------------------
    
        Estimated Total Burden Cost:
    
    N. Paperwork Reduction Act--Department of Health and Human Services
    
        Under the Paperwork Reduction Act of 1995, HHS is required to 
    provide 60-day notice in the Federal Register and solicit public 
    comment before a collection of information requirement is submitted to 
    the Office of Management and Budget (OMB) for review and approval. In 
    order to fairly evaluate whether an information collection should be 
    approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
    of 1995 requires that we solicit comment on the following issues:
         The need for the information collection and its usefulness 
    in carrying out the proper functions of our agency.
         The accuracy of our estimate of the information collection 
    burden.
    
    [[Page 16924]]
    
         The quality, utility, and clarity of the information to be 
    collected.
         Recommendations to minimize the information collection 
    burden on the affected public, including automated collection 
    techniques.
        We are, however, requesting an emergency review of this notice. In 
    compliance with the requirement of section 3506(c)(2)(A) of the 
    Paperwork Reduction Act of 1995, we have submitted to the Office of 
    Management and Budget (OMB) the following requirement for emergency 
    review. We are requesting an emergency review because the collection of 
    this information is needed before the expiration of the normal time 
    limits under OMB's regulations at 5 CFR, Part 1320, to ensure 
    compliance with section 111 of the HIPAA necessary to implement 
    congressional intent with respect to guaranteeing availability of 
    individual health insurance coverage to certain individuals with prior 
    group coverage. We cannot reasonably comply with the normal clearance 
    procedures because public harm is likely to result because eligible 
    individuals will not receive the health insurance protections under the 
    statute.
        We are requesting that OMB provide a 30-day public comment period 
    from the date of the publication, with OMB review and approval by June 
    1, 1997, and a 180-day approval. During this 180-day period, we will 
    publish a separate Federal Register notice announcing the initiation of 
    an extensive 60-day agency review and public comment period on these 
    requirements. We will submit the requirements for OMB review and an 
    extension of this emergency approval.
        Type of Information Request: New collection.
        Title of Information Collection: Information Requirements 
    Referenced in HIPAA for Group Health Plans.
        Form Number: HCFA-R-206.
        Use: This regulation and related information collection 
    requirements will ensure that group health plans provide individuals 
    with documentation necessary to demonstrate prior creditable coverage, 
    and that group health plans notify individuals of their special 
    enrollment rights in the group health insurance market.
        Frequency: On occasion.
        Affected Public: State and local governments, Business or other for 
    profit, not-for-profit institutions, individuals or households, Federal 
    government.
        Number of Respondents: 1,430.
        Total Annual Responses: Due to the rolling effective dates in the 
    statute, the number of annual responses is estimated to be 32.5 million 
    in 1997, but will increase to 41 million in 1998 and 42.5 million in 
    1999.
        Total Annual Hours Requested: 1.8 million to 3.6 million hours in 
    1997; 2.3 million to 5.8 million hours in 1998; and 2.6 million to 5.9 
    million hours in 1999.
        Total Annual Costs: $36.8 million to $53.9 million in 1997; $42.4 
    million to $76.3 million in 1998; and $43.5 million to $77.3 million in 
    1999. 45 CFR Secs. 146.120, 146.122, 146.150, 146.152, 146.160, and 
    146.180 of this document contain information collection requirements.
    
    45 CFR 146.120  Certificates and Disclosure of Previous Coverage
    
        Certificates and Disclosure of Prior Coverage.  This section sets 
    forth guidance regarding the certification and other disclosure of 
    information requirements relating to prior creditable coverage of an 
    individual. In general, the certificate must be provided in writing and 
    must include the following information: (1) The date any waiting or 
    affiliation period began, (2) the date coverage began, and (3) the date 
    coverage ended (or indicate if coverage is continuing). The regulations 
    also allow a plan or issuer in an appropriate case to simply state in 
    the certificate that the individual has at least 18 months of 
    creditable coverage that is not interrupted by a significant break and 
    indicate the date coverage ended. In general, individuals have the 
    right to receive a certificate automatically (an automatic certificate) 
    when they lose coverage under a plan and when they have a right to 
    elect COBRA continuation coverage.
        We anticipate that approximately 1,400 issuers will be required to 
    produce 30 million certifications per year based on the model 
    certificate provided. Our estimate of issuers (1,400) includes 
    commercial insurers and HMOs, but does not include some types of 
    issuers, such as Preferred Provider Organizations (PPOs); however, 
    these types of issuers are small in number. The time estimate includes 
    the time required to gather the pertinent information, create a 
    certificate, and mail the certificate to the plan participant. This 
    time estimate is based on discussions with industry individuals. We 
    believe that, as a routine business practice, the issuers' 
    administrative staff have the necessary information readily available 
    to generate the required certificates. In addition, we have determined 
    that the majority of issuers have or will have the capability to 
    automatically computer generate and disseminate the necessary 
    certification when appropriate.
        These estimates include the certificates required by issuers acting 
    as service providers on behalf of group health plans and state and 
    local government health plans. We anticipate that most, if not all, 
    state and local government health plans will contract with an issuer to 
    develop the certificate.
    
                                                                  Estimates for Certifications                                                              
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Total        Total                                                                                        
                       Year                    respondents   responses   Average time per response (range)        Burden hours (range)         Cost (range) 
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    1997.....................................        1,400   32,698,845  3.32 min.........................  1,809,119 hrs...................     $36,366,106
                                               ...........      6.34min  3,456,036 hrs....................  53,434,628......................                
    1998.....................................        1,400   28,072,131  5.19 min.........................  2,242,866 hrs...................      40,928,939
                                               ...........  ...........  12.23 min........................  5,720,198 hrs...................      74,859,759
    1999.....................................        1,400   28,055,984  5.37 min.........................  2,510,461 hrs...................      42,124,907
                                               ...........  ...........  12.41 min........................  5,804,408 hrs...................      75,760,119
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    Note: The costs above include the costs associated with issuers acting as service providers for group health plans. The costs are also included in the  
      Department of Labor's estimates.                                                                                                                      
    
        Notice to all participants: Under this section, issuers are 
    required to notify all participants at the time of enrollment stating 
    the terms of the issuer's pre-existing condition exclusion provisions, 
    the participant's right to demonstrate creditable coverage, and that 
    the issuer will assist in securing a certificate if necessary.
    
    [[Page 16925]]
    
        We have estimated the burden associated with this information 
    collection requirement to be the time required for issuers to develop 
    standardized language outlining the existence and terms of any 
    preexisting condition exclusion under the plan and the rights of 
    individuals to demonstrate creditable coverage. In specific, we 
    anticipate that issuers will be required to develop approximately 
    660,000 notices in 1997; 5.6 million notices in 1998; and 6.2 million 
    notices in 1999. At 30 seconds for each notice, we estimate the total 
    hour burden to be 4,400 hours in 1997; 30,000 hours in 1998; and 34,000 
    hours in 1999. The respective costs will be $49,000 in 1997; $330,000 
    in 1998; and $377,000 in 1999. These estimates and subsequent estimates 
    are based on an hourly wage of $11 for issuers and $15 for State and 
    local government employees. These estimates include the notices 
    required by issuers on behalf of state and local government health 
    plans, since we anticipate that most, if not all state and local 
    government health plans will contract with an issuer to develop the 
    notice. The estimates have been disaggregated below:
    
    ----------------------------------------------------------------------------------------------------------------
                                                                       State health    Local health                 
                          Year                            Issuers          plans           plans       Total notices
    ----------------------------------------------------------------------------------------------------------------
    Total notices:                                                                                                  
        1997........................................         320,000         129,826         214,880         664,706
        1998........................................       4,878,200         259,653         429,761       5,567,614
        1999........................................       5,734,300         259,653         429,761       6,189,714
    Total burden hours:                                                                                             
        1997........................................           1,592           1,078           1,784           4,454
        1998........................................          24,293           2,155           3,567          30,015
        1999........................................          28,557           2,155           3,567          34,279
    ----------------------------------------------------------------------------------------------------------------
    
        Notice to individual of period of preexisting condition exclusion. 
    Within a reasonable time following the receipt of the certificate, 
    information relating to the alternative method, or other evidence of 
    coverage, a plan or issuer is required to make a determination 
    regarding the length of any preexisting condition exclusion period that 
    applies to the individual and notify the individual of its 
    determination. Whether a determination and notification is made within 
    a reasonable period of time will depend upon the relevant facts and 
    circumstances including whether the application of the preexisting 
    condition exclusion period would prevent access to urgent medical 
    services. The individual need only be notified, however, if, after 
    considering the evidence, a preexisting condition exclusion period will 
    be imposed on the individual. The basis of the determination, including 
    the source and substance of any information on which the plan or issuer 
    relied, must be included in the notice. The plan's appeals procedures 
    and the opportunity of the individual to present additional evidence 
    must also be explained in the notification.
        We estimate that issuers will be required to develop approximately 
    29,000 notices in 1997; 425,000 notices in 1998; and 498,000 notices in 
    1999. At 2 minutes for each notice, we estimate the total hour burden 
    to be 960 hours in 1997; 14,000 hours in 1998; and 16,600 hours in 
    1999. We estimate the respective costs associated with these burdens to 
    be $10,600 in 1997; $156,000 in 1998; and $183,000 in 1999. These 
    estimates include the notices required by issuers on behalf of state 
    and local government health plans, since we anticipate that most, if 
    not all state and local government health plans will contract with an 
    issuer to develop the notice. The estimates have been disaggregated 
    below:
    
    ----------------------------------------------------------------------------------------------------------------
                                                                       State health    Local health                 
                          Year                            Issuers          plans           plans       Total notices
    ----------------------------------------------------------------------------------------------------------------
    Total notices:                                                                                                  
        1997........................................          27,650             588             766          29,004
        1998........................................         422,136           1,176           1,531         425,143
        1999........................................         496,182           1,176           1,531         498,889
    Total burden hours:                                                                                             
        1997........................................             921              20              25             966
        1998........................................          14,057              40              51          14,148
        1999........................................          16,553              40              51          16,644
    ----------------------------------------------------------------------------------------------------------------
    
    45 CFR 146.122 Special Enrollment Periods
    
        This section in the regulation provides guidance regarding new 
    enrollment rights that employees and dependents have under HIPAA. A 
    health insurance issuer offering group health insurance coverage is 
    required to provide a description of the special enrollment rights to 
    anyone who declines coverage at the time of enrollment. The regulations 
    provide a model of such a description containing the minimum 
    information mandated by the statute.
        The first burden associated with this requirement is the time 
    required for health insurance issuers and state and local government 
    health plans to incorporate the model notice into the plan's standard 
    policy information. We estimate the burden to be 2 hours annually per 
    issuer, for a total burden of 2,800 hours. The cost associated with 
    this hour burden is estimated to be $30,800 annually.
        The second burden associated with this requirement is the time 
    required to disseminate the notice to new enrollees. We estimate that 
    issuers will be required to develop approximately 1 million notices in 
    1997; 5.3 million notices in 1998; and 5.9 million notices in 1999. At 
    30 seconds for each notice, we estimate the total hour burden to be 
    8,300 hours in 1997; 43,000 hours in 1998; and 48,000 hours in 1999. We 
    have estimated the costs associated with these hour burdens to be 
    $91,000 in 1997; $469,000 in 1998; and $527,000 in
    
    [[Page 16926]]
    
    1999. These estimates include the notices required by issuers on behalf 
    of state and local government health plans, since we anticipate that 
    most, if not all state and local government health plans will contract 
    with an issuer to develop the notice. The estimates have been 
    disaggregated below:
    
    ----------------------------------------------------------------------------------------------------------------
                                                                       State health    Local health                 
                          Year                            Issuers          plans           plans       Total notices
    ----------------------------------------------------------------------------------------------------------------
    Total notices:                                                                                                  
        1997........................................         245,508         287,938         500,750       1,034,196
        1998........................................       3,750,024         575,875       1,001,500       5,327,399
        1999........................................       4,407,828         575,875       1,001,500       5,985,203
    Total burden hours:                                                                                             
        1997........................................           1,964           2,304           4,006           8,273
        1998........................................          30,000           4,607           8,012          42,619
        1999........................................          35,263           4,607           8,012          47,881
    ----------------------------------------------------------------------------------------------------------------
    
    45 CFR 146.150  Guaranteed Availability of Coverage for Employers in 
    the PHS Act Group Market Provisions
    
        This section allows a health insurance issuer to deny health 
    insurance coverage in the small group market if the issuer has 
    demonstrated to the applicable State authority (if required by the 
    State authority) that it does not have the financial reserves necessary 
    to underwrite additional coverage and that it is applying this denial 
    uniformly to all employers in the small group market in the State 
    consistent with applicable State law and without regard to the claims 
    experience of those employers and their employees (and their 
    dependents) or any health status-related factor relating to those 
    employees and dependents. Thus, issuers are only required to report to 
    the applicable State authority if they are discontinuing coverage in 
    the small group market.
        This requirement exists in the absence of this regulation because 
    under current insurance practices, State insurance departments oversee 
    discontinuance of insurance products in their State as a normal 
    business practice. Therefore, these information collection requirements 
    are exempt from the PRA under 5 CFR 1320.3(b)(2) and 5 CFR 
    1320.3(b)(3). However, under HIPAA, States must review policies during 
    their oversight process to make sure there is a guaranteed availability 
    clause in each policy. For the 37 States that currently require 
    guaranteed availability, it is our understanding that this is normal 
    business practice. For the other 18 States, however, we see this State 
    burden to be about 10 minutes per policy, since States already review 
    policies for other requirements and this process does not prescribe a 
    timetable for reviewing the policies. We see this as a total burden of 
    10,850 hours. We have estimated the cost associated with this hour 
    burden to be $163,000. If the State identifies a violation and a State 
    has to take some action, we believe that each State will be required to 
    initiate fewer than 10 administrative actions on an annual basis 
    against specific individuals or entities who failed to implement the 
    Federal guarantee availability requirements.
    
    45 CFR 146.152  Guaranteed Renewability of Coverage for Employers in 
    the PHS Act Group Market Provisions
    
        In this section issuers are only required to report if they are 
    discontinuing a particular type of coverage or discontinuing all 
    coverage. This requirement exists in the absence of this regulation 
    because under current insurance practices, State insurance departments 
    oversee discontinuance of insurance products in their State as a normal 
    business practice. Therefore, these information collection requirements 
    are exempt from the PRA under 5 CFR 1320.3(b)(2) and 5 CFR 
    1320.3(b)(3). However, under HIPAA, States must review policies during 
    their oversight process to make sure there is a guaranteed availability 
    clause in each policy. For the 43 States that currently require 
    guaranteed renewability, it is our understanding that this is normal 
    business practice. For the other 12 States, however, we see this State 
    burden to be about 10 minutes per policy, since States already review 
    policies for other requirements and this process does not prescribe a 
    timetable for reviewing the policies. We see this as a total burden of 
    6,700 hours. We have estimated the cost associated with this hour 
    burden to be $100,500. If the State identifies a violation and a State 
    has to take some action, we believe that each State will be required to 
    initiate fewer than 10 administrative actions on an annual basis 
    against specific individuals or entities who failed to implement the 
    Federal guarantee renewability requirements.
    
    45 CFR 146.160  Disclosure of Information by Issuers to Employers 
    Seeking Coverage in the Small Group Market in the PHS Act Provisions
    
        This section requires issuers to disclose information to employers 
    seeking coverage in the small group market. This section requires 
    information to be provided by a health insurance issuer offering any 
    health insurance coverage to a small employer. This information 
    includes the issuer's right to change premium rates and the factors 
    that may affect changes in premium rates, renewability of coverage, any 
    preexisting condition exclusion, any affiliation periods applied by 
    HMOs, the geographic areas served by HMOs, and the benefits and 
    premiums available under all health insurance coverage for which the 
    employer is qualified. The issuer is exempted from disclosing 
    information that is proprietary or trade secret information under 
    applicable law.
        The information described in this section must be language that is 
    understandable by the average small employer and sufficient to 
    reasonably inform small employers of their rights and obligations under 
    the health insurance coverage. This requirement is satisfied if the 
    issuer provides an outline of coverage, the minimum contribution and 
    group participation rules that apply to any particular type of 
    coverage, and any other information required by the State. An outline 
    of coverage is defined as a general description of benefits and 
    premiums. This would include an outline of coverage similar to the 
    manner in which Medigap policies are presented, allowing the employer 
    to easily compare one policy form to another to determine what is 
    covered and how much the coverage will cost.
        We have estimated the total burden associated with this activity to 
    be 2,400 hours. We anticipate that 1,200 issuers will be required to 
    provide disclosure to small employers on an annual basis. We
    
    [[Page 16927]]
    
    estimate this time to be approximately 2 hours for each issuer to 
    develop and update the standard information related to the general 
    description of benefits and premiums on an annual basis and include 
    this information in their policy information. We have estimated the 
    cost associated with this hour burden to be $36,000.
    
    45 CFR 146.180  Exclusion of Certain Plans From the PHS Act Group 
    Market Requirements
    
        Section 145.180(b) includes rules pertaining to nonfederal 
    governmental plans, which are permitted under HIPAA to elect to be 
    exempted from some or all of HIPAA's requirements in the PHS Act. The 
    regulation establishes the form and manner of the election. In 
    particular, a nonfederal governmental plan making this election is 
    required to notify plan participants, at the time of enrollment and on 
    an annual basis, of the fact and consequences of the election. The 
    burden imposed by this is the requirement for plans to disseminate 
    standard notification language describing the plans' election and the 
    consequences of this election. We anticipate that between 3,500 and 
    5,000 nonfederal governmental plans will make this election and will 
    therefore be required to disseminate notifications to their 
    participants on an annual basis. Since this is standard language that 
    will be incorporated into plans' existing policy documents, we see the 
    burden as approximately 2 hours per plan to develop and update this 
    standardized disclosure statement on an annual basis. Thus, we estimate 
    the total burden for this activity to range from 7,000 to 10,000 hours. 
    We estimate the cost associated with these hourly burdens to range from 
    $77,000 to $110,000 per year.
        The above estimate does not include the cost of disseminating the 
    notices to all plan participants on an annual basis and to new 
    enrollees at the time of enrollment. Although we do not have an 
    accurate estimate of the number of nonfederal governmental plans will 
    choose to opt out of these provisions, we have provided for a range of 
    50 to 100 percent. Using these ranges, we estimated 400,000 to 800,000 
    of these notices would need to be produced in 1997 and 800,000 to 1.6 
    million in 1998 and 1999. At 30 seconds per notice, we estimate the 
    total burden hours to range from 3,400 to 6,800 in 1997; and 6,800 to 
    13,600 in 1998 and 1999. We have estimated the costs associated with 
    these hour burdens to range from $37,400 to $74,800 in 1997; and from 
    $74,800 to $149,600 in 1998 and 1999.
        We have submitted a copy of this rule to OMB for its review of 
    these information collections. A notice will be published in the 
    Federal Register when approval is obtained. Interested persons are 
    invited to send comments regarding this burden or any other aspect of 
    these collections of information. If you comment on these information 
    collection and record keeping requirements, please mail copies directly 
    to the following addresses:
    
    Health Care Financing Administration, Office of Financial and Human 
    Resources, Management Planning and Analysis Staff, Room C2-26-17, 7500 
    Security Boulevard, Baltimore, MD 21244-1850. Attn: John Burke
    Office of Information and Regulatory Affairs, Office of Management and 
    Budget, Room 10235, New Executive Office Building, Washington, DC 
    20503, Attn: Allison Herron Eydt, HCFA Desk Officer.
    
    Statutory Authorities
    
        The Department of Labor interim final rule is adopted pursuant to 
    the authority contained in Section 707 of ERISA (Pub. L. 93-406, 88 
    Stat. 894; 29 U.S.C. 1135) as amended by HIPAA, (Pub. L. 104-91; 101 
    Stat. 1936; 29 U.S.C. 1181).
        The Department of Health and Human Services interim final rule is 
    adopted pursuant to the authority contained in Sections 2701, 2702, 
    2711, 2712, 2713, and 2792 of the PHS Act, as established by HIPAA, 
    (Pub. L. 104-191, 42 U.S.C. 300gg-1 through 300gg-13, and 300gg-92).
        The Department of the Treasury temporary rule is adopted pursuant 
    to the authority contained in Section.
    
    List of Subjects
    
    26 CFR Part 54
    
        Excise taxes, Health insurance, Pensions, Reporting and 
    recordkeeping requirements.
    
    29 CFR Part 2590
    
        Employee benefit plans, Employee Retirement Income Security Act, 
    Health care, Health insurance, Reporting and recordkeeping 
    requirements.
    
    45 CFR Parts 144 and 146
    
        Health care, Health insurance, Reporting and recordkeeping 
    requirements, State regulation of health insurance.
    
    Amendments to the Regulations
    
    Internal Revenue Service
    
    26 CFR Chapter 1
        Accordingly, 26 CFR part 54 is amended as follows:
    
    PART 54--PENSION EXCISE TAXES
    
        Paragraph 1. The authority citation for part 54 is amended by 
    adding entries in numerical order to read as follows:
    
        Authority: 26 U.S.C. 7805 * * *
    
        Section 54.9801-1T also issued under 26 U.S.C. 9806.
        Section 54.9801-2T also issued under 26 U.S.C. 9806.
        Section 54.9801-3T also issued under 26 U.S.C. 9806.
        Section 54.9801-4T also issued under 26 U.S.C. 9806.
        Section 54.9801-5T also issued under 26 U.S.C. 9801(c)(4), 
    9801(e)(3), and 9806
        Section 54.9801-6T also issued under 26 U.S.C. 9806.
        Section 54.9802-1T also issued under 26 U.S.C. 9806.
        Section 54.9804-1T also issued under 26 U.S.C. 9806.
        Section 54.9806-1T also issued under 26 U.S.C. 9806.
    
        Par. 2. Sections 54.9801-1T, 54.9801-2T, 54.9801-3T, 54.9801-4T, 
    54.9801-5T, 54.9801-6T, 54.9802-1T, 54.9804-1T, and 54.9806-1T are 
    added to read as follows:
    
    
    Sec. 54.9801-1T  Basis and scope (temporary).
    
        (a) Statutory basis. Sections 54.9801-1T through 54.9801-6T, 
    54.9802-1T, 54.9804-1T, and 54.9806-1T (portability sections) implement 
    Chapter 100 of Subtitle K of the Internal Revenue Code of 1986.
        (b) Scope. A group health plan may provide greater rights to 
    participants and beneficiaries than those set forth in these 
    portability sections. These portability sections set forth minimum 
    requirements for group health plans concerning:
        (1) Limitations on a preexisting condition exclusion period.
        (2) Certificates and disclosure of previous coverage.
        (3) Rules relating to creditable coverage.
        (4) Special enrollment periods.
        (c) Similar Requirements Under the Public Health Service Act and 
    Employee Retirement Income Security Act. Sections 2701, 2702, 2721, and 
    2791 of the Public Health Service Act and sections 701, 702, 703, 705, 
    and 706 of the Employee Retirement Income Security Act of 1974 impose 
    requirements similar to those imposed under Chapter 100 of Subtitle K 
    of the Code with respect to health insurance issuers offering group 
    health insurance coverage. See 45 CFR parts 144, 146 and 148 and 29 CFR 
    part 2590. See also Part B of Title XXVII of the Public Health Service 
    Act and 45 CFR part 148 for other rules applicable to health insurance 
    offered in the individual market (defined in Sec. 54.9801-2T).
    
    [[Page 16928]]
    
    Sec. 54.9801-2T  Definitions (temporary).
    
        Unless otherwise provided, the definitions in this section govern 
    in applying the provisions of Secs. 54.9801-1T through 54.9801-6T, 
    54.9802-1T, 54.9804-1T, and 54.9806-1T.
        Affiliation period means a period of time that must expire before 
    health insurance coverage provided by an HMO becomes effective, and 
    during which the HMO is not required to provide benefits.
        COBRA definitions:
        (1) COBRA means Title X of the Consolidated Omnibus Budget 
    Reconciliation Act of 1985, as amended.
        (2) COBRA continuation coverage means coverage, under a group 
    health plan, that satisfies an applicable COBRA continuation provision.
        (3) COBRA continuation provision means sections 601-608 of the 
    ERISA, section 4980B of the Code (other than paragraph (f)(1) of such 
    section 4980B insofar as it relates to pediatric vaccines), and Title 
    XXII of the PHSA.
        (4) Exhaustion of COBRA continuation coverage means that an 
    individual's COBRA continuation coverage ceases for any reason other 
    than either failure of the individual to pay premiums on a timely 
    basis, or for cause (such as making a fraudulent claim or an 
    intentional misrepresentation of a material fact in connection with the 
    plan). An individual is considered to have exhausted COBRA continuation 
    coverage if such coverage ceases--
        (i) Due to the failure of the employer or other responsible entity 
    to remit premiums on a timely basis; or
        (ii) When the individual no longer resides, lives, or works in a 
    service area of an HMO or similar program (whether or not within the 
    choice of the individual) and there is no other COBRA continuation 
    coverage available to the individual.
        Condition means a medical condition.
        Creditable coverage means creditable coverage within the meaning of 
    Sec. 54.9801-4T(a).
        Employee Retirement Income Security Act of 1974 (ERISA) means the 
    Employee Retirement Income Security Act of 1974, as amended (29 U.S.C. 
    1001 et seq.).
        Enroll means to become covered for benefits under a group health 
    plan (i.e., when coverage becomes effective), without regard to when 
    the individual may have completed or filed any forms that are required 
    in order to enroll in the plan. For this purpose, an individual who has 
    health insurance coverage under a group health plan is enrolled in the 
    plan regardless of whether the individual elects coverage, the 
    individual is a dependent who becomes covered as a result of an 
    election by a participant, or the individual becomes covered without an 
    election.
        Enrollment date definitions (enrollment date and first day of 
    coverage) are set forth in Sec. 54.9801-3T(a)(2) (i) and (ii).
        Excepted benefits means the benefits described as excepted in 
    Sec. 54.9804-1T(b).
        Genetic information means information about genes, gene products, 
    and inherited characteristics that may derive from the individual or a 
    family member. This includes information regarding carrier status and 
    information derived from laboratory tests that identify mutations in 
    specific genes or chromosomes, physical medical examinations, family 
    histories, and direct analysis of genes or chromosomes.
        Group health insurance coverage means health insurance coverage 
    offered in connection with a group health plan.
        Group health plan means a plan (including a self-insured plan) of, 
    or contributed to by, an employer (including a self-employed person) or 
    employee organization to provide health care (directly or otherwise) to 
    the employees, former employees, the employer, others associated or 
    formerly associated with the employer in a business relationship, or 
    their families.
        Group market means the market for health insurance coverage offered 
    in connection with a group health plan. (However, certain very small 
    plans may be treated as being in the individual market, rather than the 
    group market; see the definition of individual market in this section.)
        Health insurance coverage means benefits consisting of medical care 
    (provided directly, through insurance or reimbursement, or otherwise) 
    under any hospital or medical service policy or certificate, hospital 
    or medical service plan contract, or HMO contract offered by a health 
    insurance issuer. However, benefits described in Sec. 54.9804-1T(b)(2) 
    are not treated as benefits consisting of medical care.
        Health insurance issuer or issuer means an insurance company, 
    insurance service, or insurance organization (including an HMO) that is 
    required to be licensed to engage in the business of insurance in a 
    State and that is subject to State law that regulates insurance (within 
    the meaning of section 514(b)(2) of ERISA). Such term does not include 
    a group health plan.
        Health maintenance organization or HMO means--
        (1) A federally qualified health maintenance organization (as 
    defined in section 1301(a) of the PHSA);
        (2) An organization recognized under State law as a health 
    maintenance organization; or
        (3) A similar organization regulated under State law for solvency 
    in the same manner and to the same extent as such a health maintenance 
    organization.
        Individual health insurance coverage means health insurance 
    coverage offered to individuals in the individual market, but does not 
    include short-term, limited duration insurance. For this purpose, 
    short-term, limited duration insurance means health insurance coverage 
    provided pursuant to a contract with an issuer that has an expiration 
    date specified in the contract (taking into account any extensions that 
    may be elected by the policyholder without the issuer's consent) that 
    is within 12 months of the date such contract becomes effective. 
    Individual health insurance coverage can include dependent coverage.
        Individual market means the market for health insurance coverage 
    offered to individuals other than in connection with a group health 
    plan. Unless a State elects otherwise in accordance with section 
    2791(e)(1)(B)(ii) of the PHSA, such term also includes coverage offered 
    in connection with a group health plan that has fewer than two 
    participants as current employees on the first day of the plan year.
        Issuer means a health insurance issuer.
        Late enrollment definitions (late enrollee and late enrollment) are 
    set forth in Sec. 54.9801-3T(a)(2) (iii) and (iv).
        Medical care has the meaning given such term by section 213(d) of 
    the Internal Revenue Code, determined without regard to section 
    213(d)(1)(C) and so much of section 213(d)(1)(D) as relates to 
    qualified long-term care insurance.
        Medical condition on condition means any condition, whether 
    physical or mental, including, but not limited to, any condition 
    resulting from illness, injury (whether or not the injury is 
    accidental), pregnancy, or congenital malformation. However, genetic 
    information is not a condition.
        Placement, or being placed, for adoption means the assumption and 
    retention of a legal obligation for total or partial support of a child 
    by a person with whom the child has been placed in anticipation of the 
    child's adoption. The child's placement for adoption with such person 
    terminates upon the termination of such legal obligation.
        Plan year means the year that is designated as the plan year in the 
    plan
    
    [[Page 16929]]
    
    document of a group health plan, except that if the plan document does 
    not designate a plan year or if there is no plan document, the plan 
    year is--
        (1) The deductible/limit year used under the plan;
        (2) If the plan does not impose deductibles or limits on a yearly 
    basis, then the plan year is the policy year;
        (3) If the plan does not impose deductibles or limits on a yearly 
    basis, and either the plan is not insured or the insurance policy is 
    not renewed on an annual basis, then the plan year is the employer's 
    taxable year; or
        (4) In any other case, the plan year is the calendar year.
        Preexisting condition exclusion means a limitation or exclusion of 
    benefits relating to a condition based on the fact that the condition 
    was present before the first day of coverage, whether or not any 
    medical advice, diagnosis, care, or treatment was recommended or 
    received before that day. A preexisting condition exclusion includes 
    any exclusion applicable to an individual as a result of information 
    that is obtained relating to an individual's health status before the 
    individual's first day of coverage, such as a condition identified as a 
    result of a pre-enrollment questionnaire or physical examination given 
    to the individual, or review of medical records relating to the 
    preenrollment period.
        Public health plan means public health plan within the meaning of 
    Sec. 54.9801-4T(a)(1)(ix).
        Public Health Service Act (PHSA) means the Public Health Service 
    Act (42 U.S.C. 201, et seq.).
        Significant break in coverage means a significant break in coverage 
    within the meaning of Sec. 54.9801-4T(b)(2)(iii).
        Special enrollment date means a special enrollment date within the 
    meaning of Sec. 54.9801-6T(d).
        State health benefits risk pool means a State health benefits risk 
    pool within the meaning of Sec. 54.9801-4T(a)(1)(vii).
        Waiting period means the period that must pass before an employee 
    or dependent is eligible to enroll under the terms of a group health 
    plan. If an employee or dependent enrolls as a late enrollee or on a 
    special enrollment date, any period before such late or special 
    enrollment is not a waiting period. If an individual seeks and obtains 
    coverage in the individual market, any period after the date the 
    individual files a substantially complete application for coverage and 
    before the first day of coverage is a waiting period.
    
    
    Sec. 54.9801-3T  Limitations on preexisting condition exclusion period 
    (temporary).
    
        (a) Preexisting condition exclusion--(1) In general. Subject to 
    paragraph (b) of this section, a group health plan may impose, with 
    respect to a participant or beneficiary, a preexisting condition 
    exclusion only if the requirements of this paragraph (a) are satisfied. 
    (See PHSA section 2701 and ERISA section 701 under which this 
    prohibition is also imposed on a health insurance issuer offering group 
    health insurance coverage.)
        (i) 6-month look-back rule. A preexisting condition exclusion must 
    relate to a condition (whether physical or mental), regardless of the 
    cause of the condition, for which medical advice, diagnosis, care, or 
    treatment was recommended or received within the 6-month period ending 
    on the enrollment date.
        (A) For purposes of this paragraph (a)(1)(i), medical advice, 
    diagnosis, care, or treatment is taken into account only if it is 
    recommended by, or received from, an individual licensed or similarly 
    authorized to provide such services under State law and operating 
    within the scope of practice authorized by State law.
        (B) For purposes of this paragraph (a)(1)(i), the 6-month period 
    ending on the enrollment date begins on the 6-month anniversary date 
    preceding the enrollment date. For example, for an enrollment date of 
    August 1, 1998, the 6-month period preceding the enrollment date is the 
    period commencing on February 1, 1998 and continuing through July 31, 
    1998. As another example, for an enrollment date of August 30, 1998, 
    the 6-month period preceding the enrollment date is the period 
    commencing on February 28, 1998 and continuing through August 29, 1998.
        (C) The rules of this paragraph (a)(1)(i) are illustrated by the 
    following examples:
    
        Example 1. (i) Individual A is treated for a medical condition 7 
    months before the enrollment date in Employer R's group health plan. 
    As part of such treatment, A's physician recommends that a follow-up 
    examination be given 2 months later. Despite this recommendation, A 
    does not receive a follow-up examination and no other medical 
    advice, diagnosis, care, or treatment for that condition is 
    recommended to A or received by A during the 6-month period ending 
    on A's enrollment date in Employer R's plan.
        (ii) In this Example 1, Employer R's plan may not impose a 
    preexisting condition exclusion period with respect to the condition 
    for which A received treatment 7 months prior to the enrollment 
    date.
        Example 2. (i) Same facts as Example 1 except that Employer R's 
    plan learns of the condition and attaches a rider to A's policy 
    excluding coverage for the condition. Three months after enrollment, 
    A's condition recurs, and Employer R's plan denies payment under the 
    rider.
        (ii) In this Example 2, the rider is a preexisting condition 
    exclusion and Employer R's plan may not impose a preexisting 
    condition exclusion with respect to the condition for which A 
    received treatment 7 months prior to the enrollment date.
        Example 3. (i) Individual B has asthma and is treated for that 
    condition several times during the 6-month period before B's 
    enrollment date in Employer S's plan. The plan imposes a 12-month 
    preexisting condition exclusion. B has no prior creditable coverage 
    to reduce the exclusion period. Three months after the enrollment 
    date, B begins coverage under Employer S's plan. Two months later, B 
    is hospitalized for asthma.
        (ii) In this Example 3, Employer S's plan may exclude payment 
    for the hospital stay and the physician services associated with 
    this illness because the care is related to a medical condition for 
    which treatment was received by B during the 6-month period before 
    the enrollment date.
        Example 4. (i) Individual D, who is subject to a preexisting 
    condition exclusion imposed by Employer U's plan, has diabetes, as 
    well as a foot condition caused by poor circulation and retinal 
    degeneration (both of which are conditions that may be directly 
    attributed to diabetes). After enrolling in the plan, D stumbles and 
    breaks a leg.
        (ii) In this Example 4, the leg fracture is not a condition 
    related to D's diabetes, even though poor circulation in D's 
    extremities and poor vision may have contributed towards the 
    accident. However, any additional medical services that may be 
    needed because of D's preexisting diabetic condition that would not 
    be needed by another patient with a broken leg who does not have 
    diabetes may be subject to the preexisting condition exclusion 
    imposed under Employer U's plan.
    
        (ii) Maximum length of preexisting condition exclusion (the look-
    forward rule). A preexisting condition exclusion is not permitted to 
    extend for more than 12 months (18 months in the case of a late 
    enrollee) after the enrollment date. For purposes of this paragraph 
    (a)(1)(ii), the 12-month and 18-month periods after the enrollment date 
    are determined by reference to the anniversary of the enrollment date. 
    For example, for an enrollment date of August 1, 1998, the 12-month 
    period after the enrollment date is the period commencing on August 1, 
    1998 and continuing through July 31, 1999.
        (iii) Reducing a preexisting condition exclusion period by 
    creditable coverage. The period of any preexisting condition exclusion 
    that would otherwise apply to an individual under a group health plan 
    is reduced by the number of days of creditable coverage the individual 
    has as of the enrollment date, as counted under Sec. 54.9801-4T. For 
    purposes of Sec. 54.9801-1T through Sec. 54.9801-6T, the phrase ``days 
    of creditable coverage'' has the same meaning as the phrase
    
    [[Page 16930]]
    
    ``aggregate of the periods of creditable coverage'' as such term is 
    used in section 9801(a)(3) of the Internal Revenue Code.
        (iv) Other standards. See Sec. 54.9802-1T for other standards that 
    may apply with respect to certain benefit limitations or restrictions 
    under a group health plan.
        (2) Enrollment definitions--(i) Enrollment date means the first day 
    of coverage or, if there is a waiting period, the first day of the 
    waiting period.
        (ii)(A) First day of coverage means, in the case of an individual 
    covered for benefits under a group health plan in the group market, the 
    first day of coverage under the plan and, in the case of an individual 
    covered by health insurance coverage in the individual market, the 
    first day of coverage under the policy.
        (B) The following example illustrates the rule of paragraph 
    (a)(2)(ii)(A) of this section:
    
        Example. (i) Employer V's group health plan provides for 
    coverage to begin on the first day of the first payroll period 
    following the date an employee is hired and completes the applicable 
    enrollment forms, or on any subsequent January 1 after completion of 
    the applicable enrollment forms. Employer V's plan imposes a 
    preexisting condition exclusion for 12 months (reduced by the 
    individual's creditable coverage) following an individual's 
    enrollment date. Employee E is hired by Employer V on October 13, 
    1998 and then on October 14, 1998 completes and files all the forms 
    necessary to enroll in the plan. E's coverage under the plan becomes 
    effective on October 25, 1998 (which is the beginning of the first 
    payroll period after E's date of hire).
        (ii) In this Example, E's enrollment date is October 13, 1998 
    (which is the first day of the waiting period for E's enrollment and 
    is also E's date of hire). Accordingly, with respect to E, the 6-
    month period in paragraph (a)(1)(i) would be the period from April 
    13, 1998 through October 12, 1998, the maximum permissible period 
    during which Employer V's plan could apply a preexisting condition 
    exclusion under paragraph (a)(1)(ii) would be the period from 
    October 13, 1998 through October 12, 1999, and this period would be 
    reduced under paragraph (a)(1)(iii) by E's days of creditable 
    coverage as of October 13, 1998.
    
        (iii) Late enrollee means an individual whose enrollment in a plan 
    is a late enrollment.
        (iv) (A) Late enrollment means enrollment under a group health plan 
    other than on--
        (1) The earliest date on which coverage can become effective under 
    the terms of the plan; or
        (2) A special enrollment date for the individual.
        (B) If an individual ceases to be eligible for coverage under the 
    plan by terminating employment, and then subsequently becomes eligible 
    for coverage under the plan by resuming employment, only eligibility 
    during the individual's most recent period of employment is taken into 
    account in determining whether the individual is a late enrollee under 
    the plan with respect to the most recent period of coverage. Similar 
    rules apply if an individual again becomes eligible for coverage 
    following a suspension of coverage that applied generally under the 
    plan.
        (v) Examples. The rules of this paragraph (a)(2) are illustrated by 
    the following examples:
    
        Example 1. (i) Employee F first becomes eligible to be covered 
    by Employer W's group health plan on January 1, 1999, but elects not 
    to enroll in the plan until April 1, 1999. April 1, 1999 is not a 
    special enrollment date for F.
        (ii) In this Example 1, F would be a late enrollee with respect 
    to F's coverage that became effective under the plan on April 1, 
    1999.
        Example 2. (i) Same as Example 1, except that F does not enroll 
    in the plan on April 1, 1999 and terminates employment with Employer 
    W on July 1, 1999, without having had any health insurance coverage 
    under the plan. F is rehired by Employer W on January 1, 2000 and is 
    eligible for and elects coverage under Employer W's plan effective 
    on January 1, 2000.
        (ii) In this Example 2, F would not be a late enrollee with 
    respect to F's coverage that became effective on January 1, 2000.
    
        (b) Exceptions pertaining to preexisting condition exclusions--(1) 
    Newborns--
        (i) In general. Subject to paragraph (b)(3) of this section, a 
    group health plan may not impose any preexisting condition exclusion 
    with regard to a child who, as of the last day of the 30-day period 
    beginning with the date of birth, is covered under any creditable 
    coverage. Accordingly, if a newborn is enrolled in a group health plan 
    (or other creditable coverage) within 30 days after birth and 
    subsequently enrolls in another group health plan without a significant 
    break in coverage, the other plan may not impose any preexisting 
    condition exclusion with regard to the child.
        (ii) Example. The rule of this paragraph (b)(1) is illustrated by 
    the following example:
    
        Example. (i) Seven months after enrollment in Employer W's group 
    health plan, Individual E has a child born with a birth defect. 
    Because the child is enrolled in Employer W's plan with in 30 days 
    of birth, no preexisting condition exclusion may be imposed with 
    respect to the child under Employer W's plan. Three months after the 
    child's birth, E commences employment with Employer X and enrolls 
    with the child in Employer X's plan 45 days after leaving Employer 
    W's plan. Employer X's plan imposes a 12-month exclusion for any 
    preexisting condition.
        (ii) In this Example, Employer X's plan may not impose any 
    preexisting condition exclusion with respect to E's child because 
    the child was covered within 30 days of birth and had no significant 
    break in coverage. This result applies regardless of whether E's 
    child is included in the certificate of creditable coverage provided 
    to E by Employer W indicating 300 days of dependent coverage or 
    receives a separate certificate indicating 90 days of coverage. 
    Employer X's plan may impose a preexisting condition exclusion with 
    respect to E for up to 2 months for any preexisting condition of E 
    for which medical advice, diagnosis, care, or treatment was 
    recommended or received by E within the 6-month period ending on E's 
    enrollment date in Employer X's plan.
    
        (2) Adopted children. Subject to paragraph (b)(3) of this section, 
    a group health plan may not impose any preexisting condition exclusion 
    in the case of a child who is adopted or placed for adoption before 
    attaining 18 years of age and who, as of the last day of the 30-day 
    period beginning on the date of the adoption or placement for adoption, 
    is covered under creditable coverage. This rule does not apply to 
    coverage before the date of such adoption or placement for adoption.
        (3) Break in coverage. Paragraphs (b)(1) and (2) of this section no 
    longer apply to a child after a significant break in coverage.
        (4) Pregnancy. A group health plan may not impose a preexisting 
    condition exclusion relating to pregnancy as a preexisting condition.
        (5) Special enrollment dates. For special enrollment dates relating 
    to new dependents, see Sec. 54.9801-6T(b).
        (c) Notice of plan's preexisting condition exclusion. A group 
    health plan may not impose a preexisting condition exclusion with 
    respect to a participant or dependent of the participant before 
    notifying the participant, in writing, of the existence and terms of 
    any preexisting condition exclusion under the plan and of the rights of 
    individuals to demonstrate creditable coverage (and any applicable 
    waiting periods) as required by Sec. 54.9801-5T. The description of the 
    rights of individuals to demonstrate creditable coverage includes a 
    description of the right of the individual to request a certificate 
    from a prior plan or issuer, if necessary, and a statement that the 
    current plan or issuer will assist in obtaining a certificate from any 
    prior plan or issuer, if necessary.
    
    
    Sec. 54.9801-4T  Rules relating to creditable coverage (temporary).
    
        (a) General rules--(1) Creditable coverage. For purposes of this 
    section,
    
    [[Page 16931]]
    
    except as provided in paragraph (a)(2) of this section, the term 
    creditable coverage means coverage of an individual under any of the 
    following:
        (i) A group health plan as defined in Sec. 54.9801-2T.
        (ii) Health insurance coverage as defined in Sec. 54.9801-2T 
    (whether or not the entity offering the coverage is subject to chapter 
    100 of Subtitle K, and without regard to whether the coverage is 
    offered in the group market, the individual market, or otherwise).
        (iii) Part A or B of Title XVIII of the Social Security Act 
    (Medicare).
        (iv) Title XIX of the Social Security Act (Medicaid), other than 
    coverage consisting solely of benefits under section 1928 of the Social 
    Security Act (the program for distribution of pediatric vaccines).
        (v) Title 10 U.S.C. Chapter 55 (medical and dental care for members 
    and certain former members of the uniformed services, and for their 
    dependents; for purposes of Title 10 U.S.C. Chapter 55, uniformed 
    services means the armed forces and the Commissioned Corps of the 
    National Oceanic and Atmospheric Administration and of the Public 
    Health Service).
        (vi) A medical care program of the Indian Health Service or of a 
    tribal organization.
        (vii) A State health benefits risk pool. For purposes of this 
    section, a State health benefits risk pool means--
        (A) An organization qualifying under section 501(c)(26);
        (B) A qualified high risk pool described in section 2744(c)(2) of 
    the PHSA; or
        (C) Any other arrangement sponsored by a State, the membership 
    composition of which is specified by the State and which is established 
    and maintained primarily to provide health insurance coverage for 
    individuals who are residents of such State and who, by reason of the 
    existence or history of a medical condition--
        (1) Are unable to acquire medical care coverage for such condition 
    through insurance or from an HMO; or
        (2) Are able to acquire such coverage only at a rate which is 
    substantially in excess of the rate for such coverage through the 
    membership organization.
        (viii) A health plan offered under Title 5 U.S.C. Chapter 89 (the 
    Federal Employees Health Benefits Program).
        (ix) A public health plan. For purposes of this section, a public 
    health plan means any plan established or maintained by a State, 
    county, or other political subdivision of a State that provides health 
    insurance coverage to individuals who are enrolled in the plan.
        (x) A health benefit plan under section 5(e) of the Peace Corps Act 
    (22 U.S.C. 2504(e)).
        (2) Excluded coverage. Creditable coverage does not include 
    coverage consisting solely of coverage of expected benefits (described 
    in Sec. 54.9804-1T).
        (3) Methods of counting creditable coverage. For purposes of 
    reducing any preexisting condition exclusion period, as provided under 
    Sec. 54.9801-3T(a)(1)(iii), a group health plan determines the amount 
    of an individual's creditable coverage by using the standard method 
    described in paragraph (b) of this section, except that the plan may 
    use the alternative method under paragraph (c) of this section with 
    respect to any or all of the categories of benefits described under 
    paragraph (c)(3) of this section or may provide that a health insurance 
    issuer offering health insurance coverage under the plan may use the 
    alternative method of counting creditable coverage.
        (b) Standard method--(1) Specific benefits not considered. Under 
    the standard method, a group health plan determines the amount of 
    creditable coverage without regard to the specific benefits included in 
    the coverage.
        (2) Counting creditable coverage--(i) Based on days. For purposes 
    of reducing the preexisting condition exclusion period, a group health 
    plan determines the amount of creditable coverage by counting all the 
    days that the individual has under one or more types of creditable 
    coverage. Accordingly, if on a particular day, an individual has 
    creditable coverage from more than one source, all the creditable 
    coverage on that day is counted as one day. Further, any days in a 
    waiting period for a plan or policy are not creditable coverage under 
    the plan or policy.
        (ii) Days not counted before significant break in coverage. Days of 
    creditable coverage that occur before a significant break in coverage 
    are not required to be counted.
        (iii) Definition of significant break in coverage. A significant 
    break in coverage means a period of 63 consecutive days during all of 
    which the individual does not have any creditable coverage, except that 
    neither a waiting period nor an affiliation period is taken into 
    account in determining a significant break in coverage. (See section 
    731(b)(2)(iii) of ERISA and section 2723(b)(2)(iii) of the PHSA which 
    exclude from preemption State insurance laws that require a break of 
    more than 63 days before an individual has a significant break in 
    coverage for purposes of State law.)
        (iv) Examples. The following examples illustrate how creditable 
    coverage is counted in reducing preexisting condition exclusion periods 
    under this paragraph (b)(2):
    
        Example 1. (i) Individual A works for Employer P and has 
    creditable coverage under Employer P's plan for 18 months before A's 
    employment terminates. A is hired by Employer Q, and enrolls in 
    Employer Q's group health plan, 64 days after the last date of 
    coverage under Employer P's plan. Employer Q's plan has a 12-month 
    preexisting condition exclusion period.
        (ii) In this Example 1, because A had a break in coverage of 63 
    days, Employer Q's plan may disregard A's prior coverage and A may 
    be subject to a 12-month preexisting condition exclusions period.
        Example 2. (i) Same facts as Example 1, except that A is hired 
    by Employer Q, and enrolls in Employer Q's plan, on the 63rd day 
    after the last date of coverage under Employer P's plan.
        (ii) In this Example 2, A has a break in coverage of 62 days. 
    Because A's break in coverage is not a significant break in 
    coverage, Employer Q's plan must count A's prior creditable coverage 
    for purposes of reducing the plan's preexisting condition exclusion 
    as it applies to A.
        Example 3. (i) Same facts as Example 1, except that Employer Q's 
    plan provides benefits through an insurance policy that, as required 
    by applicable State insurance laws, defines a significant break in 
    coverage as 90 days.
        (ii) In this Example 3, the issuer that provides group health 
    insurance to Employer Q's plan must count A's period of creditable 
    coverage prior to the 63-day break.
        Example 4. (i) Same facts as Example 3, except that Employer Q's 
    plan is a self-insured plan, and, thus is not subject to State 
    insurance laws.
        (ii) In this Example 4, the plan is not governed by the longer 
    break rules under State insurance law and A's previous coverage may 
    be disregarded.
        Example 5. (i) Individual B begins employment with Employer R 45 
    days after terminating coverage under a prior group health plan. 
    Employer R's plan has a 30-day waiting period before coverage 
    begins. B enrolls in Employer R's plan when first eligible.
        (ii) In this Example 5, B does not have a significant break in 
    coverage for purposes of determining whether B's prior coverage must 
    be counted by Employer R's plan. B has only a 44-day break in 
    coverage because the 30-day waiting period is not taken into account 
    in determining a significant break in coverage.
        Example 6. (i) Individual C works for Employer S and has 
    creditable coverage under Employer S's plan for 200 days before C's 
    employment is terminated and coverage ceases. C is then unemployed 
    for 51 days before being hired by Employer T. Employer T's plan has 
    a 3-month waiting period. C works for Employer T for 2 months and 
    then terminates employment. Eleven days after terminating employment 
    with Employer T, C begins working for Employer U. Employer
    
    [[Page 16932]]
    
    U's plan has no waiting period, but has a 6-month preexisting 
    condition exclusion period.
        (ii) In this Example 6, C does not have a significant break in 
    coverage because, after disregarding the waiting period under 
    Employer T's plan, C had only a 62-break in coverage (51 days plus 
    11 days). Accordingly, C has 200 days of creditable coverage and 
    Employer U's plan may not apply its 6-month preexisting condition 
    exclusion period with respect to C.
        Example 7. (i) Individual D terminates employment with Employer 
    V on January 13, 1998 after being covered for 24 months under 
    Employer V's group health plan. On March 17, the 63rd day without 
    coverage, D applies for a health insurance policy in the individual 
    market. D's application is accepted and the coverage is made 
    effective May 1.
        (ii) In this Example 7, because D applied for the policy before 
    the end of the 63rd day, coverage under the policy ultimately became 
    effective, the period between the date of application and the first 
    day of coverage is a waiting period and no significant break in 
    coverage occurred even though the actual period without coverage was 
    107 days.
        Example 8. (i) Same facts as Example 7, except that D's 
    application for a policy in the individual market is denied.
        (ii) In this Example 8, because D did not obtain coverage 
    following application, D incurred a significant break in coverage on 
    the 64th day.
    
        (v) Other permissible counting methods--(A) Rule. Notwithstandng 
    any other provision of this paragraph (b)(2), for purposes of reducing 
    a preexisting condition exclusion period (but not for purposes of 
    issuing a certificate under Sec. 54,9801-5T), a group health plan may 
    determine the amount of creditable coverage in any other manner that is 
    at least as favorable to the individual as the method set forth in this 
    paragraph (b)(2), subject to the requirements of other applicable law.
        (B) Example. The rule of this paragraph (b)(2)(v) is illustrated by 
    the following example:
    
        Example. (i) Individual F has coverage under group health plan Y 
    from January 3, 1997 through March 25, 1997. F then becomes covered 
    by group health plan Z. F's enrollment date in Plan Z is May 1, 
    1997. Plan Z has a 12-month preexisting condition exclusion period.
        (ii) In this Example, Plan Z may determine, in accordance with 
    the rules prescribed in paragraph (b)(2) (i), (ii), and (iii), that 
    F has 82 days of creditable coverage (29 days in January, 28 days in 
    February, and 25 days in March). Thus, the preexisting condition 
    exclusion period will no longer apply to F on February 8, 1998 (82 
    days before the 12-month anniversary of her enrollment (May 1)), For 
    administrative convenience, however, Plan Z may consider that the 
    preexisting condition exclusion period will no longer apply to F on 
    the first day of the month (February 1).
    
        (c) Alternative method--(1) Specific benefits considered. Under the 
    alternative method, a group health plan determines the amount of 
    creditable coverage based on coverage within any category of benefits 
    described in paragraph (c)(3) of this section and not based on coverage 
    for any other benefits. The plan may use the alternative method for any 
    or all the categories. The plan may apply a different preexisting 
    condition exclusion period with respect to each category (and may apply 
    a different preexisting condition exclusion period for benefits that 
    are not within any category). The creditable coverage determined for a 
    category of benefits applies only for purposes of reducing the 
    preexisting condition exclusion period with respect to that category. 
    An individual's creditable coverage for benefits that are not within 
    any category for which the alternative method is being used is 
    determined under the standard method of paragraph (b) of this section.
        (2) Uniform application. A plan using the alternative method is 
    required to apply it uniformly to all participants and beneficiaries 
    under the plan. A plan that provides benefits through one or more 
    insurance policies (or in part through one or more insurance policies) 
    will not fail the uniform application requirement of this paragraph 
    (c)(2) if the alternative method is used (or not used) separately with 
    respect to participants and beneficiaries under any policy, provided 
    that the alternative method is applied uniformly with respect to all 
    coverage under that policy. The use of the alternative method is 
    required to be set forth in the plan.
        (3) Categories of benefits. The alternative method for counting 
    creditable coverage may be used for coverage for the following 
    categories of benefits--
        (i) Mental health;
        (ii) Substance abuse treatment;
        (iii) Prescription drugs;
        (iv) Dental care; or
        (v) Vision care.
        (4) Plan notice. If the alternative method is used, the plan is 
    required to--
        (i) State prominently that the plan is using the alternative method 
    of counting creditable coverage in disclosure statements concerning the 
    plan, and state this to each enrollee at the time of enrollment under 
    the plan; and
        (ii) Include in these statements a description of the effect of 
    using the alternative method, including an identification of the 
    categories used.
        (5) Disclosure of information on previous benefits. See 
    Sec. 54.9801-5T(b) for special rules concerning disclosure of coverage 
    to a plan (or issuer) using the alternative method of counting 
    creditable coverage under this paragraph (c).
        (6) Counting creditable coverage--(i) In general. Under the 
    alternative method, the group health plan counts creditable coverage 
    within a category if any level of benefits is provided within the 
    category. Coverage under a reimbursement account or arrangement such as 
    a flexible spending arrangement (as defined in section 106(c)(2) of the 
    Internal Revenue Code) does not constitute coverage within any 
    category.
        (ii) Special rules. In counting an individual's creditable coverage 
    under the alternative method, the group health plan first determines 
    the amount of the individual's creditable coverage that may be counted 
    under paragraph (b) of this section, up to a total of 365 days of the 
    most recent creditable coverage (546 days for a late enrollee). The 
    period over which this creditable coverage is determined is referred to 
    as the determination period. Then, for the category specified under the 
    alternative method, the plan counts within the category all days of 
    coverage that occurred during the determination period (whether or not 
    a significant break in coverage for that category occurs), and reduces 
    the individual's preexisting condition exclusion period for that 
    category by that number of days. The plan may determine the amount of 
    creditable coverage in any other reasonable manner, uniformly applied, 
    this is at least as favorable to the individual.
        (iii) Example. The rules of this paragraph (c)(6) are illustrated 
    by the following example:
    
        Example. (i) Individual D enrolls in Employer V's plan on 
    January 1, 2001. Coverage under the plan includes prescription drug 
    benefits. On April 1, 2001, the plan ceases providing prescription 
    drug benefits. D's employment with Employer V ends on January 1, 
    2002, after D was covered under Employer V's group health plan for 
    365 days. D enrolls in Employer Y's plan on February 1, 2002 (D's 
    enrollment date). Employer Y's plan uses the alternative method of 
    counting creditable coverage and imposes a 12-month preexisting 
    condition exclusion on prescription drug benefits.
        (ii) In this Example, Employer Y's plan may impose a 275-day 
    preexisting condition exclusion with respect to D for prescription 
    drug benefits because D had 90 days of creditable coverage relating 
    to prescription drug benefits within D's determination period.
    
    
    Sec. 54.9801-5T  Certification and disclosure of previous coverage 
    (temporary).
    
        (a) Certificate of creditable coverage--(1) Entities required to 
    provide certificate--(i) In general. A group
    
    [[Page 16933]]
    
    health plan is required to furnish certificates of creditable coverage 
    in accordance with this paragraph (a) of this section. (See PHSA 
    section 2701(e) and ERISA section 701(e) under which this obligation is 
    also imposed on a health insurance issuer offering group health 
    insurance coverage.)
        (ii) Duplicate certificates not required. An entity required to 
    provide a certificate under this paragraph (a)(1) for an individual is 
    deemed to have satisfied the certification requirements for that 
    individual if another party provides the certificate, but only to the 
    extent that information relating to the individual's creditable 
    coverage and waiting or affiliation period is provided by the other 
    party. For example, a group health plan is deemed to have satisfied the 
    certification requirement with respect to a participant or beneficiary 
    if any other entity actually provides a certificate that includes the 
    information required under paragraph (a)(3) of this section with 
    respect to the participant or beneficiary.
        (iii) Special rule for group health plans. To the extent coverage 
    under a plan consists of group health insurance coverage, the plan is 
    deemed to have satisfied the certification requirements under this 
    paragraph (a)(1) if any issuer offering the coverage is required to 
    provide the certificates pursuant to an agreement between the plan and 
    the issuer. For example, if there is an agreement between an issuer and 
    the employer sponsoring the plan under which the issuer agrees to 
    provide certificates for individuals covered under the plan, and the 
    issuer fails to provide a certificate to an individual when the plan 
    would have been required to provide one under this paragraph (a), then 
    the plan does not violate the certification requirements of this 
    paragraph (a) (though the issuer would have violated the certification 
    requirements pursuant to section 2701(e) of the PHSA and section 701(e) 
    of ERISA).
        (iv) Special rules relating to issuers providing coverage under a 
    plan--(A)(1) Responsibility of issuer for coverage period. See 29 CFR 
    2590.701-5 and 45 CFR 146.115, under which an issuer is not required to 
    provide information regarding coverage provided to an individual by 
    another party.
        (2) Example. The rule referenced by this paragraph (a)(1)(iv)(A) is 
    illustrated by the following example:
    
        Example. (i) A plan offers coverage with an HMO option from one 
    issuer and an indemnity option from a different issuer. The HMO has 
    not entered into an agreement with the plan to provide certificates 
    as permitted under paragraph (a)(1)(iii) of this section.
        (ii) In this Example, if an employee switches from the indemnity 
    option to the HMO option and later ceases to be covered under the 
    plan, any certificate provided by the HMO is not required to provide 
    information regarding the employee's coverage under the indemnity 
    option.
    
        (B) (1) Cessation of issuer coverage prior to cessation of coverage 
    under a plan. If an individual's coverage under an issuer's policy 
    ceases before the individual's coverage under the plan ceases, the 
    issuer is required (under section 2701(e) of the PHSA and section 
    701(e) of ERISA) to provide sufficient information to the plan (or to 
    another party designated by the plan) to enable a certificate to be 
    provided by the plan (or other party), after cessation of the 
    individual's coverage under the plan, that reflects the period of 
    coverage under the policy. The provision of that information to the 
    plan will satisfy the issuer's obligation to provide an automatic 
    certificate for that period of creditable coverage for the individual 
    under paragraph (a)(2)(ii) and (3) of this section. In addition, an 
    issuer providing that information is required to cooperate with the 
    plan in responding to any request made under paragraph (b)(2) of this 
    section (relating to the alternative method of counting creditable 
    coverage). If the individual's coverage under the plan ceases at the 
    time the individual's coverage under the issuer's policy ceases, the 
    issuer must provide an automatic certificate under paragraph (a)(2)(ii) 
    of this section. An issuer may presume that an individual whose 
    coverage ceases at a time other than the effective date for changing 
    enrollment options has ceased to be covered under the plan.
        (2) Example. The rule of this paragraph (a)(1)(iv)(B) is 
    illustrated by the following example:
    
        Example. (i) A group health plan provides coverage under an HMO 
    option and an indemnity option with a different issuer, and only 
    allows employees to switch on each January 1. Neither the HMO nor 
    the indemnity issuer has entered into an agreement with the plan to 
    provide automatic certificates as permitted under paragraph 
    (a)(2)(ii) of this section.
        (ii) In this Example, if an employee switches from the indemnity 
    option to the HMO option on January 1, the issuer must provide the 
    plan (or a person designated by the plan) with appropriate 
    information with respect to the individual's coverage with the 
    indemnity issuer. However, if the individual's coverage with the 
    indemnity issuer ceases at a date other than January 1, the issuer 
    is instead required to provide the individual with an automatic 
    certificate.
    
        (2) Individuals for whom certificate must be provided; timing of 
    issuance--(i) Individuals. A certificate must be provided, without 
    charge, for participants or dependents who are or were covered under a 
    group health plan upon the occurrence of any of the events described in 
    paragraph (a)(2)(ii) or (iii) of this section.
        (ii) Issuance of automatic certificates. The certificates described 
    in this paragraph (a)(2)(ii) are referred to as automatic certificates.
        (A) Qualified beneficiaries upon a qualifying event. In the case of 
    an individual who is a qualified beneficiary (as defined in section 
    4980B(g)(1)) entitled to elect COBRA continuation coverage, an 
    automatic certificate is required to be provided at the time the 
    individual would lose coverage under the plan in the absence of COBRA 
    continuation coverage or alternative coverage elected instead of COBRA 
    continuation coverage. A plan satisfies this requirement if it provides 
    the automatic certificate no later than the time a notice is required 
    to be furnished for a qualifying event under section 4980B(f)(6) 
    (relating to notices required under COBRA).
        (B) Other individuals when coverage ceases. In the case of an 
    individual who is not a qualified beneficiary entitled to elect COBRA 
    continuation coverage, an automatic certificate is required to be 
    provided at the time the individual ceases to be covered under the 
    plan. A plan satisfies this requirement if it provides the automatic 
    certificate within a reasonable time period thereafter. In the case of 
    an individual who is entitled to elect to continue coverage under a 
    State program similar to COBRA and who receives the automatic 
    certificate not later than the time a notice is required to be 
    furnished under the State program, the certificate is deemed to be 
    provided within a reasonable time period after the cessation of 
    coverage under the plan.
        (C) Qualified beneficiaries when COBRA ceases. In the case of an 
    individual who is a qualified beneficiary and has elected COBRA 
    continuation coverage (or whose coverage has continued after the 
    individual became entitled to elect COBRA continuation coverage), an 
    automatic certificate is to be provided at the time the individual's 
    coverage under the plan ceases. A plan satisfies this requirement if it 
    provides the automatic certificate within a reasonable time after 
    coverage ceases (or after the expiration of any grace period for 
    nonpayment of premiums). An automatic certificate is required to be 
    provided to such an individual regardless of whether the individual has 
    previously received an automatic certificate under paragraph 
    (a)(2)(ii)(A) of this section.
    
    [[Page 16934]]
    
        (iii) Any individual upon request. Requests for certificates are 
    permitted to be made by, or on behalf of, an individual within 24 
    months after coverage ceases. Thus, for example, a plan in which an 
    individual enrolls may, if authorized by the individual, request a 
    certificate of the individual's creditable coverage on behalf of the 
    individual from a plan in which the individual was formerly enrolled. 
    After the request is received, a plan or issuer is required to provide 
    the certificate by the earliest date that the plan, acting in a 
    reasonable and prompt fashion, can provide the certificate. A 
    certificate is required to be provided under this paragraph (a)(2)(iii) 
    even if the individual has previously received an automatic certificate 
    under paragraph (a)(2)(ii) of this section.
        (iv) Examples. The following examples illustrate the rules of this 
    paragraph (a)(2):
    
        Example 1. (i) Individual A terminates employment with Employer 
    Q. A is a qualified beneficiary entitled to elect COBRA continuation 
    coverage under Employer q's group health plan. A notice of the 
    rights provided under COBRA is typically furnished to qualified 
    beneficiaries under the plan within 10 days after a covered employee 
    terminates employment.
        (ii) In this Example 1, the automatic certificate may be 
    provided at the same time that A is provided the COBRA notice.
        Example 2., (i) Same facts as Example 1, except that the 
    automatic certificate for A is not completed by the time the COBRA 
    notice is furnished to A.
        (ii) In this Example 2, the automatic certificate may be 
    provided within the period permitted by law for the delivery of 
    notices under COBRA.
        Example 3. (i) Employer R maintains an insured group health 
    plan. R has never had 20 employees and thus R's plan is not subject 
    to the COBRA continuation coverage provisions. However, R is in a 
    State that has a State program similar to COBRA. B terminates 
    employment with R and loses coverage under R's plan.
        (ii) In this Example 3, the automatic certificate may be 
    provided not later than the time a notice is required to be 
    furnished under the State program.
        Example 4. (i) Individual C terminates employment with Employer 
    S and receives both a notice of C's rights under COBRA and an 
    automatic certificate. C elects COBRA continuation coverage under 
    Employer S's group health plan. After four months of COBRA 
    continuation coverage and the expiration of a 30-day grace period, 
    S's group health plan determines that C's COBRA continuation 
    coverage has ceased due to failure to make a timely payment for 
    continuation coverage.
        (ii) In this Example 4, the plan must provide an updated 
    automatic certificate to C within a reasonable time after the end of 
    the grace period.
        Example 5. (i) Individual D is currently covered under the group 
    health plan of Employer T. D requests a certificate, as premitted 
    under paragraph (a)(2)(iii). Under the procedure for Employer T's 
    plan, certificates are mailed (by first class mail) 7 business days 
    following receipt of the request. This date reflects the earliest 
    date that the plan, acting in a reasonable and prompt fashion, can 
    provide certificates.
        (ii) In this Example 5, the plan's procedure satisfies paragraph 
    (a)(2)(iii) of this section.
    
        (3) Form and content of certificate-- (i) Written certificate--(A) 
    In general. Except as provided in paragraph (a)(3)(i)(B) of this 
    section, the certificate must be provided in writing (including any 
    form approved by the Secretary as a writing).
        (B) Other permissible forms. No written certificate is required to 
    be provided under paragraph (a) with respect to a particular event 
    described in paragraph (a)(2) (ii) or (iii) of this section if----
        (1) An individual is entitled to receive a certificate;
        (2) The individual requests that the certificate be sent to another 
    plan or issuer instead of to the individual;
        (3) The plan or issuer that would otherwise receive the certificate 
    agrees to accept the information in this paragraph (a)(3) through means 
    other than a written certificate (e.g., by telephone); and
        (4) The receiving plan or issuer receives such information from the 
    sending plan or issuer in such form within the time periods required 
    under paragraph (a)(2) of this section.
        (ii) Required information. The certificate must include the 
    following----
        (A) The date the certificate is issued;
        (B) The name of the group health plan that provided the coverage 
    described in the certificate;
        (C) The name of the participant or dependent with respect to whom 
    the certificate applies, and any other information necessary for the 
    plan providing the coverage specified in the certificate to identify 
    the individual, such as the individual's identification number under 
    the plan and the name of the participant if the certificate is for (or 
    includes) a dependent;
        (D) The name, address, and telephone number of the plan 
    administrator or issuer required to provide the certificate;
        (E) The telephone number to call for further information regarding 
    the certificate (if different from paragraph (a)(3)(ii)(D) of this 
    section);
        (F) Either--
        (1) A statement that an individual has at least 18 months (for this 
    purpose, 546 days is deemed to be 18 months) of creditable coverage, 
    disregarding days of creditable coverage before a significant break in 
    coverage, or
        (2) The date any waiting period (and affiliation period, if 
    applicable) began and the date creditable coverage began; and
        (G) The date creditable coverage ended, unless the certificate 
    indicates that creditable coverage is continuing as of the date of the 
    certificate.
        (iii) Periods of coverage under certificate. If an automatic 
    certificate is provided pursuant to paragraph (a)(2)(ii) of this 
    section, the period that must be included on the certificate is the 
    last period of continuous coverage ending on the date coverage ceased. 
    If an individual requests a certificate pursuant to paragraph 
    (a)(2)(iii) of this section, a certificate must be provided for each 
    period of continuous coverage ending within the 24-month period ending 
    on the date of the request (or continuing on the date of the request). 
    A separate certificate may be provided for each such period of 
    continuous coverage.
        (iv) Combining information for families. A certificate may provide 
    information with respect to both a participant and the participant's 
    dependents if the information is identical for each individual or, if 
    the information is not identical, certificates may be provided on one 
    form if the form provides all the required information for each 
    individual and separately states the information that is not identical.
        (v) Model certificate. The requirements of paragraph (a)(3)(ii) of 
    this section are satisfied if the plan provides a certificate in 
    accordance with a model certificate authorized by the Secretary.
        (vi) Excepted benefits; categories of benefits. No certificate is 
    required to be furnished with respect to excepted benefits described in 
    Sec. 54.9804-1T. In addition, the information in the certificate 
    regarding coverage is not required to specify categories of benefits 
    described in Sec. 54.9801-4T(c) (relating to the alternative method of 
    counting creditable coverage). However, if excepted benefits are 
    provided concurrently with other creditable coverage (so that the 
    coverage does not consist solely of excepted benefits), information 
    concerning the benefits may be required to be disclosed under paragraph 
    (b) of this section.
        (4) Procedures--(i) Method of delivery. The certificate is required 
    to be provided to each individual described in paragraph (a)(2) of this 
    section or an entity requesting the certificate on behalf of the 
    individual. The certificate
    
    [[Page 16935]]
    
    may be provided by first-class mail. If the certificate or certificates 
    are provided to the participant and the participant's spouse at the 
    participant's last known address, then the requirements of this 
    paragraph (a)(4) are satisfied with respect to all individuals residing 
    at that address. If a dependent's last known address is different than 
    the participant's last known address, a separate certificate is 
    required to be provided to the dependent at the dependent's last known 
    address. If separate certificates are being provided by mail to 
    individuals who reside at the same address, separate mailings of each 
    certificate are not required.
        (ii) Procedure for requesting certificates. A plan or issuer must 
    establish a procedure for individuals to request and receive 
    certificates pursuant to paragraph (a)(2)(iii) of this section.
        (iii) Designated recipients. If an automatic certificate is 
    required to be provided under paragraph (a)(2)(ii) of this section, and 
    the individual entitled to receive the certificate designates another 
    individual or entity to receive the certificate, the plan or issuer 
    responsible for providing the certificate is permitted to provide the 
    certificate to the designated party. If a certificate is required to be 
    provided upon request under paragraph (a)(2)(iii) of this section and 
    the individual entitled to receive the certificate designates another 
    individual or entity to receive the certificate, the plan or issuer 
    responsible for providing the certificate is required to provide the 
    certificate to the designated party.
        (5) Special rules concerning dependent coverage--(i)(A) Reasonable 
    efforts. A plan is required to use reasonable efforts to determine any 
    information needed for a certificate relating to the dependent 
    coverage. In any case in which an automatic certificate is required to 
    be furnished with respect to a dependent under paragraph (a)(2)(ii) of 
    this section, no individual certificate is required to be furnished 
    until the plan knows (or making reasonable efforts should know) of the 
    dependent's cessation of coverage under the plan.
        (B) Example. The rules of this paragraph (a)(5) are illustrated by 
    the following example:
    
        Example. (i) A group health plan covers employees and their 
    dependents. The plan annually requests all employees to provide 
    updated information regarding dependents, including the specific 
    date on which an employee has a new dependent or on which a person 
    ceases to be a dependent of the employee.
        (ii) In this Example, the plan has satisfied the standard in 
    this paragraph (a)(5)(i) of this section that it make reasonable 
    efforts to determine the cessation of dependents' coverage and the 
    related dependent coverage information.
    
        (ii) Special rules for demonstrating coverage. If a certificate 
    furnished by a plan or issuer does not provide the name of any 
    dependent of an individual covered by the certificate, the individual 
    may, if necessary, use the procedures described in paragraph (c)(4) of 
    this section for demonstrating dependent status. In addition, an 
    individual may, if necessary, use these procedures to demonstrate that 
    a child was enrolled within 30 days of birth, adoption, or placement 
    for adoption. See Sec. 54.9801-3T(b), under which such a child would 
    not be subject to a preexisting condition exclusion.
        (iii) Transition rule for dependent coverage through June 30, 
    1998--(A) In general. A group health plan that cannot provide the names 
    of dependents (or related coverage information) for purposes of 
    providing a certificate of coverage for a dependent may satisfy the 
    requirements of paragraph (a)(3)(ii)(C) of this section by providing 
    the name of the participant covered by the group health plan and 
    specifying that the type of coverage described in the certificate is 
    for dependent coverage (e.g., family coverage or employee-plus-spouse 
    coverage).
        (B) Certificates provided on request. For purposes of certificates 
    provided on the request of, or on behalf of, an individual pursuant to 
    paragraph (a)(2)(iii) of this section, a plan must make reasonable 
    efforts to obtain and provide the names of any dependent covered by the 
    certificate where such information is requested to be provided. If a 
    certificate does not include the name of any dependent of an individual 
    covered by the certificate, the individual may, if necessary, use the 
    procedures described in paragraph (c) of this section for submitting 
    documentation to establish that the credible coverage in the 
    certificate applies to the dependent.
        (C) Demonstrating a dependent's creditable coverage. See paragraph 
    (c)(4) of this section for special rules to demonstrate dependent 
    status.
        (D) Duration. This paragraph (a)(5)(iii) is only effective for 
    certifications provided with respect to events occurring through June 
    30, 1998.
        (6) Special specification rules for entities not subject to Chapter 
    100 of Subtitle K of the Internal Revenue Code--(i) Issuers. For rules 
    requiring that issuers in the group and individual markets provide 
    certificates consistent with the rules in this section, see section 
    701(e) of ERISA and sections 2701(e), 2721(b)(1)(B), and 2743 of the 
    PHSA.
        (ii) Other entities. For special rules requiring that certain other 
    entities, not subject to Chapter 100 of Subtitle K of the Internal 
    Revenue Code, provide certificates consistent with the rules in the 
    section, see section 2791(a)(3) of the PHSA applicable to entities 
    described in sections 2701(c)(1) (C), (D), (E), and (F) (relating to 
    Medicare, Medicaid, CHAMPUS, and Indian Health Service), section 
    2721(b)(1)(A) of the PHSA applicable to nonfederal governmental plans 
    generally, and section 2721(b)(2)(C)(ii) of the PHSA applicable to 
    nonfederal governmental plans that elect to be excluded from the 
    requirements of Subparts 1 and 3 of Part A of Title XXVII of the PHSA.
        (b) Disclosure of coverage to a plan, or issuer, using the 
    alternative method of counting creditable coverage--(1) In general. If 
    an individual enrolls in a group health plan with respect to which the 
    plan (or issuer) uses the alternative method of counting creditable 
    coverage described in Sec. 54.9801-4T(c), the individual provides a 
    certificate of coverage under paragraph (a) of this section, and the 
    plan (or issuer) in which the individual enrolls so requests, the 
    entity that issued the certificate (the prior entity) is required to 
    disclose promptly to a requesting plan (or issuer) (the requesting 
    entity) the information set forth in paragraph (b)(2) of this section.
        (2) Information to be disclosed. The prior entity is required to 
    identify to the requesting entity the categories of benefits with 
    respect to which the requesting entity is using the alternative method 
    of counting creditable coverage, and the requesting entity may identify 
    specific information that the requesting entity reasonably needs to 
    order to determine the individual's creditable coverage with respect to 
    any such category. The prior entity is required to disclose promptly to 
    the requesting entity the creditable coverage information so requested.
        (3) Charge for providing information. The prior entity furnishing 
    the information under paragraph (b) of this section may charge the 
    requesting entity for the reasonable cost of disclosing such 
    information.
        (c) Ability of an individual to demonstrate creditable coverage and 
    waiting period information--(1) In general. The rules in this paragraph 
    (c) implement section 9801(c)(4), which permits individuals to 
    establish creditable coverage through means other than certificates, 
    and section 9801(e)(3), which requires the Secretary to establish rules 
    designed to prevent an
    
    [[Page 16936]]
    
    individual's subsequent coverage under a group health plan or health 
    insurance coverage from being adversely affected by an entity's failure 
    to provide a certificate with respect to that individual. If the 
    accuracy of a certificate is contested or a certificate is unavailable 
    when needed by the individual, the individual has the right to 
    demonstrate creditable coverage (and waiting or affiliation periods) 
    through the presentation of documents or other means. For example, the 
    individual may make such a demonstration when--
        (i) An entity has failed to provide a certificate within the 
    required time period;
        (ii) The individual has creditable coverage but an entity may not 
    be required to provide a certificate of the coverage pursuant to 
    paragraph (a) of this section;
        (iii) The coverage is for a period before July 1, 1996;
        (iv) The individual has an urgent medical condition that 
    necessitates a determination before the individual can deliver a 
    certificate to the plan; or
        (v) The individual lost a certificate that the individual had 
    previously received and is unable to obtain another certificate.
        (2) Evidence of creditable coverage--(i) Consideration of evidence. 
    A plan is required to take into account all information that it obtains 
    or that is presented on behalf of an individual to make a 
    determination, based on the relevant facts and circumstances, whether 
    an individual has creditable coverage and is entitled to offset all or 
    a portion of any preexisting condition exclusion period. A plan shall 
    treat the individual as having furnished a certificate under paragraph 
    (a) of this section if the individual attests to the period of 
    creditable coverage, the individual also presents relevant 
    corroborating evidence of some creditable coverage during the period, 
    and the individual cooperates with the plan's efforts to verify the 
    individual's coverage. For this purpose, cooperation includes providing 
    (upon the plan's or issuer's request) a written authorization for the 
    plan to request a certificate on behalf of the individual, and 
    cooperating in efforts to determine the validity of the corroborating 
    evidence and the dates of creditable coverage. While a plan may refuse 
    to credit coverage where the individual fails to cooperate with the 
    plan's or issuer's efforts to verify coverage, the plan may not 
    consider an individual's inability to obtain a certificate to be 
    evidence of the absence of creditable coverage.
        (ii) Documents. Documents that may establish creditable coverage 
    (and waiting periods or affiliation periods) in the absence of a 
    certificate include explanations of benefit claims (EOB) or other 
    correspondence from a plan or issuer indicating coverage, pay stubs 
    showing a payroll deduction for health coverage, a health insurance 
    identification card, a certificate of coverage under a group health 
    policy, records from medical care providers indicating health coverage, 
    third party statements verifying periods of coverage, and any other 
    relevant documents that evidence periods of health coverage.
        (iii) Other evidence. Creditable coverage (and waiting period or 
    affiliation period information) may also be established through means 
    other than documentation, such as by a telephone call from the plan or 
    provider to a third party verifying creditable coverage.
        (iv) Example. The rules of this paragraph (c)(2) are illustrated by 
    the following example:
    
        Example. (i) Individual F terminates employment with Employer W 
    and, a month later, is hired by Employer X. Employer X's group 
    health plan imposes a preexisting condition exclusion of 12 months 
    on new enrollees under the plan and uses the standard method of 
    determining creditable coverage. F fails to receive a certificate of 
    prior coverage from the self-insured group health plan maintained by 
    F's prior employer, Employer W, and requests a certificate. However, 
    F (and Employer's X's plan, on F's behalf) is unable to obtain a 
    certificate from Employer W's plan. F attests that, to the best of 
    F's knowledge, F had at least 12 months of continuous coverage under 
    Employer W's plan, and that the coverage ended no earlier than F's 
    termination of employment from Employer W. In addition, F presents 
    evidence of coverage, such as an explanation of benefits for a claim 
    that was made during the relevant period.
        (ii) In this Example, based solely on these facts, F has 
    demonstrated creditable coverage for the 12 months of coverage under 
    Employer W's plan in the same manner as if F had presented a written 
    certificate of creditable coverage.
    
        (3) Demonstrating categories of creditable coverage. Procedures 
    similar to those described in this paragraph (c) apply in order to 
    determine an individual's creditable coverage with respect to any 
    category under paragraph (b) of this section (relating to determining 
    creditable coverage under the alternative method).
        (4) Demonstrating dependent status. If, in the course of providing 
    evidence (including a certificate) of creditable coverage, an 
    individual is required to demonstrate dependent status, the group 
    health plan or issuer is required to treat the individual as having 
    furnished a certificate showing the dependent status if the individual 
    attests to such dependency and the period of such status and the 
    individual cooperates with the plan's or issuer's efforts to verify the 
    dependent status.
        (d) Determination and notification of creditable coverage--(1) 
    Reasonable time period. In the event that a group health plan receives 
    information under paragraph (a) of this section (certifications), 
    paragraph (b) of this section (disclosure of information relating to 
    the alternative method), or paragraph (c) of this section (other 
    evidence of creditable coverage), the plan is required, within a 
    reasonable time period following receipt of the information, to make a 
    determination regarding the indivdiual's period of creditable coverage 
    and notify the individual of the determination in accordance with 
    paragraph (d)(2) of this section. Whether a determination and 
    notification regarding an individual's creditable coverage is made 
    within a reasonable time period is determined based on the relevant 
    facts and circumstances. Relevant facts and circumstances include 
    whether a plan's application of a preexisting condition exclusion would 
    prevent an individual from having access to urgent medical services.
        (2) Notification to individual of period of preexisting condition 
    exclusion. A plan seeking to impose a preexisting condition exclusion 
    is required to disclose to the individual, in writing, its 
    determination of any preexisting condition exclusion period that 
    applies to the individual, and the basis for such determination, 
    including the source and substance of any information on which the plan 
    relied. In addition, the plan is required to provide the individual 
    with a written explanation of any appeal procedures established by the 
    plan, and with a reasonable opportunity to submit additional evidence 
    of creditable coverage. However, nothing in this paragraph (d) or 
    paragraph (c) of this section prevents a plan from modifying an initial 
    determination of creditable coverage if it determines that the 
    individual did not have the claimed creditable coverage, provided 
    that--
        (i) A notice of such reconsideration, as described in this 
    paragraph (d), is provided to the individual; and
        (ii) Until the final determination is made, the plan, for purposes 
    of approving access to medical services (such as a pre-surgery 
    authorization), acts in a manner consistent with the initial 
    determination.
        (3) Examples. The following examples illustrate this paragraph (d):
    
        Example 1. (i) Individual G is hired by Employer Y. Employer Y's 
    group health plan
    
    [[Page 16937]]
    
    imposes a preexisting condition exclusion for 12 months with respect 
    to new enrollees and uses the standard method of determining 
    creditable coverage. Employer Y's plan determines that G is subject 
    to a 4-month preexisting condition exclusion, based on a certificate 
    of creditable coverage that is provided by G to Employer Y's plan 
    indicating 8 months of coverage under G's prior group health plan.
        (ii) In this Example 1, Employer Y's plan must notify G within a 
    reasonable period of time following receipt of the certificate that 
    G is subject to a 4-month preexisting condition exclusion beginning 
    on G's enrollment date in Y's plan.
        Example 2. (i) Same facts as in Example 1, except that Employer 
    Y's plan determines that G has 14 months of creditable coverage 
    based on G's certificate indicating 14 months of creditable coverage 
    under G's prior plan.
        (ii) In this Example 2. Employer Y's plan is not required to 
    notify G that G will not be subject to a preexisting condition 
    exclusion.
        Example 3. (i) Individual H is hired by Employer Z. Employer Z's 
    group health plan imposes a preexisting condition exclusion for 12 
    months with respect to new enrollees and uses the standard method of 
    determining creditable coverage. H develops an urgent health 
    condition before receiving a certificate of prior coverage. H 
    attests to the period of prior coverage, presents corroborating 
    documentation of the coverage period, and authorizes the plan to 
    request a certificate on H's behalf.
        (ii) In this Example 3, Employer Z's plan must review the 
    evidence presented by H. In addition, the plan must make a 
    determination and notify H regarding any preexisting condition 
    exclusion period that applies to H (and the basis of such 
    determination) within a reasonable time period following receipt of 
    the evidence that is consistent with the urgency of H's health 
    condition (this determination may be modified as permitted under 
    paragraph (d)(2) of this section).
    
    
    Sec. 54.9801-6T  Special enrollment periods (temporary).
    
        (a) Special enrollment for certain individuals who lose coverage--
    (1) In general. A group health plan is required to permit employees and 
    dependents described in paragraph (a)(2), (3) or (4) of this section to 
    enroll for coverage under the terms of the plan if the conditions in 
    paragraph (a)(5) of this section are satisfied and the enrollment is 
    requested within the period described in paragraph (a)(6) of this 
    section. The enrollment is effective at the time described in paragraph 
    (a)(7) of this section. The special enrollment rights under this 
    paragraph (a) apply without regard to the dates on which an individual 
    would otherwise be able to enroll under the plan. (See PHSA section 
    2701(f)(1) and ERISA section 701(f)(1) under which this obligation is 
    also imposed on a health insurance issuer offering group health 
    insurance coverage.)
        (2) Special enrollment of an employee only. An employee is 
    described in this paragraph (a)(2) if the employee is eligible, but not 
    enrolled, for coverage under the terms of the plan and, when enrollment 
    was previously offered to the employee under the plan and was declined 
    by the employee, the employee was covered under another group health 
    plan or had other health insurance coverage.
        (3) Special enrollment of dependents only. A dependent is described 
    in this paragraph (a)(3) if the dependent is a dependent of an employee 
    participating in the plan, the dependent is eligible, but not enrolled, 
    for coverage under the terms of the plan, and, when enrollment was 
    previously offered under the plan was declined, the dependent was 
    covered under another group health plan or had other health insurance 
    coverage.
        (4) Special enrollment of both employee and dependent. An employee 
    and any dependent of the employee are described in this paragraph 
    (a)(4) if they are eligible, but not enrolled, for coverage under the 
    terms of the plan and, when enrollment was previously offered to the 
    employee or dependent under the plan and was declined, the employee or 
    dependent was covered under another group health plan or had other 
    health insurance coverage.
        (5) Conditions for special enrollment. An employee or dependent is 
    eligible to enroll during a special enrollment period if each of the 
    following applicable conditions is met:
        (i) When the employee declined enrollment for the employee or the 
    dependent, the employee stated in writing that coverage under another 
    group health plan or other health insurance coverage was the reason for 
    declining enrollment. This paragraph (a)(5)(i) applies only if--
        (A) The plan required such a statement when the employee declined 
    enrollment; and
        (B) The employee is provided with notice of the requirement to 
    provide the statement in this paragraph (a)(5)(i) (and the consequences 
    of the employee's failure to provide the statement) at the time the 
    employee declined enrollment.
        (ii)(A) When the employee declined enrollment for the employee or 
    dependent under the plan, the employee or dependent had CORRA 
    continuation coverage under another plan and COBRA continuation 
    coverage under that other plan has since been exhausted; or
        (B) If the other coverage that applied to the employee or dependent 
    when enrollment was declined was not under a COBRA continuation 
    provision, either the other coverage has been terminated as a result of 
    loss of eligibility for the coverage or employer contributions towards 
    the other coverage have been terminated. For this purpose, loss of 
    eligibility for coverage includes a loss of coverage as a result of 
    legal separation, divorce, death, termination of employment, reduction 
    in the number of hours of employment, and any loss of eligibility after 
    a period that is measured by reference to any of the foregoing. Thus, 
    for example, if an employee's coverage ceases following a termination 
    of employment and the employee is eligible for but fails to elect COBRA 
    continuation coverage, this is treated as a loss of eligibility under 
    this paragraph (a)(5)(ii)(B). However, loss of eligibility does not 
    include a loss due to failure of the individual or the participant to 
    pay premiums on a timely basis or termination of coverage for cause 
    (such as making a fraudulent claim or an intentional misrepresentation 
    of a material fact in connection with the plan). In addition, for 
    purposes of this paragraph (a)(5)(ii)(B), employer contributions 
    include contributions by any current or former employer (of the 
    individual or another person) that was contributing to coverage for the 
    individual.
        (6) Length of special enrollment period. The employee is required 
    to request enrollment (for the employee or the employee's dependent, as 
    described in paragraph (a) (2), (3), or (4) of this section) not later 
    than 30 days after the exhaustion of the other coverage described in 
    paragraph (a)(5)(ii)(A) of this section or termination of the other 
    coverage as a result of the loss of eligibility for the other coverage 
    for items described in paragraph (a)(5)(ii)(B) of this section or 
    following the termination of employer contributions toward that other 
    coverage. The plan may impose the same requirements that apply to 
    employees who are otherwise eligible under the plan to immediately 
    request enrollment for coverage (e.g., that the request be made in 
    writing).
        (7) Effective date of enrollment. Enrollment is effective not later 
    than the first day of the first calendar month beginning after the date 
    the completed request for enrollment is received.
        (b) Special enrollment with respect to certain dependent 
    beneficiaries--(1) In general. A group health plan that makes coverage 
    available with respect to dependents of a participant is required to 
    provide a special enrollment period to permit individuals described in 
    paragraph (b) (2), (3), (4), (5), or (6) of this section to be enrolled 
    for coverage under the terms of the plan if the enrollment is requested 
    within the time
    
    [[Page 16938]]
    
    period described in paragraph (b)(7) of this section. The enrollment is 
    effective at the time described in paragraph (b)(8) of this section. 
    The special enrollment rights under this paragraph (b) apply without 
    regard to the dates on which an individual would otherwise be able to 
    enroll under the plan.
        (2) Special enrollment of an employee who is eligible but not 
    enrolled. An individual is described in this paragraph (b)(2) if the 
    individual is an employee who is eligible, but not enrolled, in the 
    plan, the individual would be a participant but for a prior election by 
    the individual not to enroll in the plan during a previous enrollment 
    period, and a person becomes a dependent of the individual through 
    marriage, birth, or adoption or placement for adoption.
        (3) Special enrollment of a spouse of a participant. An individual 
    is described in this paragraph (b)(3) if either--
        (i) The individual becomes the spouse of a participant; or
        (ii) The individual is a spouse of the participant and a child 
    becomes a dependent of the participant through birth, adoption or 
    placement for adoption.
        (4) Special enrollment of an employee who is eligible but not 
    enrolled and the spouse of such employee. An employee who is eligible, 
    but not enrolled, in the plan, and an individual who is a dependent of 
    such employee, are described in this paragraph (b)(4) if the employee 
    would be a participant but for a prior election by the employee not to 
    enroll in the plan during a previous enrollment period, and either--
        (i) The employee and the individual become married; or
        (ii) The employee and individual are married and a child becomes a 
    dependent of the employee through birth, adoption or placement for 
    adoption.
        (5) Special enrollment of a dependent of a participant. An 
    individual is described in this paragraph (b)(5) if the individual is a 
    dependent of a participant and the individual becomes a dependent of 
    such participant through marriage, birth, or adoption or placement for 
    adoption.
        (6) Special enrollment of an employee who is eligible but not 
    enrolled and a new dependent. An employee who is eligible, but not 
    enrolled, in the plan, and an individual who is a dependent of the 
    employee, are described in this paragraph (b)(6) if the employee would 
    be a participant but for a prior election by the employee not to enroll 
    in the plan during a previous enrollment period, and the dependent 
    becomes a dependent of the employee through marriage, birth, or 
    adoption or placement for adoption.
        (7) Length of special enrollment period. The special enrollment 
    period under paragraph (b)(1) of this section is a period of not less 
    than 30 days and begins on the date of the marriage, birth, or adoption 
    or placement for adoption (except that such period does not begin 
    earlier than the date the plan makes dependent coverage generally 
    available).
        (8) Effective date of enrollment. Enrollment is effective--
        (i) In the case of marriage, not later than the first day of the 
    first calendar month beginning after the date the completed request for 
    enrollment is received by the plan;
        (ii) In the case of a dependent's birth, the date of such birth; 
    and
        (iii) In the case of a dependent's adoption or placement for 
    adoption, the date of such adoption or placement for adoption.
        (9) Example. The rules of this paragraph (b) are illustrated by the 
    following example:
    
        Example. (i) Employee A is hired on September 3, 1998 by 
    Employer X, which has a group health plan in which A can elect to 
    enroll either for employee-only coverage, for employee-plus-spouse 
    coverage, or for family coverage, effective on the first day of any 
    calendar quarter thereafter. A is married and has no children. A 
    does not elect to join Employer X's plan (for employee-only 
    coverage, employee-plus-spouse coverage, or family coverage) on 
    October 1, 1998 or January 1, 1999. On February 15, 1999, a child is 
    placed for adoption with A and A's spouse.
        (ii) In this Example, the conditions for special enrollment of 
    an employee with a new dependent under paragraph (b)(2) of this 
    section are satisfied, the conditions for special enrollment of an 
    employee and a spouse with a new dependent under paragraph (b)(4) of 
    this section are satisfied, and the conditions for special 
    enrollment of an employee and a new dependent under paragraph (b)(6) 
    of this section are satisfied. Accordingly, Employer X's plan will 
    satisfy this paragraph (b) if and only if it allows A to elect, by 
    filing the required forms by March 16, 1999, to enroll in Employer 
    X's plan either with employee-only coverage, with employee-plus-
    spouse coverage, or with family coverage, effective as of February 
    15, 1999.
    
        (c) Notice of enrollment rights. On or before the time an employee 
    is offered the opportunity to enroll in a group health plan, the plan 
    is required to provide the employee with a description of the plan's 
    special enrollment rules under this section. For this purpose, the plan 
    may use the following model description of the special enrollment rules 
    under this section:
    
        If you are declining enrollment for yourself or your dependents 
    (including your spouse) because of other health insurance coverage, 
    you may in the future be able to enroll yourself or your dependents 
    in this plan, provided that you request enrollment within 30 days 
    after your other coverage ends. In addition, if you have a new 
    dependent as a result of marriage, birth, adoption, or placement for 
    adoption, you may be able to enroll yourself and your dependents, 
    provided that you request enrollment within 30 days after the 
    marriage, birth, adoption, or placement for adoption.
    
        (d) (1) Special enrollment date definition. A special enrollment 
    date for an individual means any date in paragraph (a)(7) or (b)(8) of 
    this section on which the individual has a right to have enrollment in 
    a group health plan become effective under this section.
        (2) Examples. The rules of this section are illustrated by the 
    following examples:
    
        Example 1. (i)(A) Employer Y maintains a group health plan that 
    allows employees to enroll in the plan either--
        (1) Effective on the first day of employment by an election 
    filed within three days thereafter;
        (2) Effective on any subsequent January 1 by an election made 
    during the preceding months of November or December; or
        (3) Effective as of any special enrollment date described in 
    this section.
        (B) Employee B is hired by Employer Y on March 15, 1998 and does 
    not elect to enroll in Employer Y's plan until January 31, 1999 when 
    B loses coverage under another plan. B elects to enroll in Employer 
    Y's plan effective on February 1, 1999, by filing the completed 
    request form by January 31, 1999, in accordance with the special 
    rule set forth in paragraph (a) of this section.
        (ii) In this Example 1, B has enrolled on a special enrollment 
    date because the enrollment is effective at a date described in 
    paragraph (a)(7) of this section.
        Example 2. (i) Same facts as Example 1, except that B's loss of 
    coverage under the other plan occurs on December 31, 1998 and B 
    elects to enroll in Employer Y's plan effective on January 1, 1999 
    by filing the completed request form by December 31, 1998, in 
    accordance with the special rule set forth in paragraph (a) of this 
    section.
        (ii) In this Example 2, B has enrolled on a special enrollment 
    date because the enrollment is effective at a date described in 
    paragraph (a)(7) of this section (even though this date is also a 
    regular enrollment date under the plan).
    
    
    Sec. 54.9802-1T  Prohibiting discrimination against participants and 
    beneficiaries based on a health status-related factor (temporary).
    
        (a) In eligibility to enroll--(1) In general. Subject to paragraph 
    (a)(2) of this section, a group health plan may not establish rules for 
    eligibility (including continued eligibility) of any individual to 
    enroll under the terms of the plan based on any of the following
    
    [[Page 16939]]
    
    health status-related factors in relation to the individual or a 
    dependent of the individual:
        (i) Health status.
        (ii) Medical condition (including both physical and mental 
    illnesses), as defined in Sec. 54.9801-2T.
        (iii) Claims experience.
        (iv) Receipt of health care.
        (v) Medical history.
        (vi) Genetic information, as defined in Sec. 54.9801-2T.
        (vii) Evidence of insurability (including conditions arising out of 
    acts of domestic violence).
        (viii) Disability.
        (2) No application to benefits or exclusions. To the extent 
    consistent with section 9801 and Sec. 54.9801-3T, paragraph (a)(1) of 
    this section shall not be construed--
        (i) To require a group health plan to provide particular benefits 
    other than those provided under the terms of such plan; or
        (ii) To prevent such a plan from establishing limitations or 
    restrictions on the amount, level, extent, or nature of the benefits or 
    coverage for similarly situated individuals enrolled in the plan or 
    coverage.
        (3) Construction. For purposes of paragraph (a)(1) of this section, 
    rules for eligibility to enroll include rules defining any applicable 
    waiting (or affiliation) periods for such enrollment and rules relating 
    to late and special enrollment.
        (4) Example. The following example illustrates the rules of this 
    paragraph (a):
    
        Example. (i) An employer sponsors a group health plan that is 
    available to all employees who enroll within the first 30 days of 
    their employment. However, individuals who do not enroll in the 
    first 30 days cannot enroll later unless they pass a physical 
    examination.
        (ii) In this Example, the plan discriminates on the basis of one 
    or more health status-related factors.
    
        (b) In premiums or contributions--(1) In general. A group health 
    plan may not require an individual (as a condition of enrollment or 
    continued enrollment under the plan) to pay a premium or contribution 
    that is greater than the premium or contribution for a similarly 
    situated individual enrolled in the plan based on any health status-
    related factor, in relation to the individual or a dependent of the 
    individual.
        (2) Construction. Nothing in paragraph (b)(1) of this section shall 
    be construed--
        (i) To restrict the amount that an employer may be charged by an 
    issuer for coverage under a group health plan; or
        (ii) To prevent a group health plan from establishing premium 
    discounts or rebates or modifying otherwise applicable copayments or 
    deductibles in return for adherence to a bona fide wellness program. 
    For purposes of this section, a bona fide wellness program is a program 
    of health promotion and disease prevention.
        (3) Example. The rules of this paragraph (b) are illustrated by the 
    following example:
    
        Example. (i) Plan X offers a premium discount to participants 
    who adhere to a cholesterol-reduction wellness program. Enrollees 
    are expected to keep a diary of their food intake over 6 weeks. They 
    periodically submit the diary to the plan physician who responds 
    with suggested diet modifications. Enrollees are to modify their 
    diets in accordance with the physician's recommendations. At the end 
    of the 6 weeks, enrollees are given a cholesterol test and those who 
    achieve a count under 200 receive a premium discount.
        (ii) In this Example, because enrollees who otherwise comply 
    with the program may be unable to achieve a cholesterol count under 
    200 due to a health status-related factor, this is not a bona fide 
    wellness program and such discounts would discriminate impermissibly 
    based on one or more health status-related factors. However, if, 
    instead, individuals covered by the plan were entitled to receive 
    the discount for complying with the diary and dietary requirements 
    and were not required to pass a cholesterol test, the program would 
    be a bona fide wellness program.
    
    
    Sec. 54.9804-1T  Special rules relating to group health plans 
    (temporary).
    
        (a) General exception small group health plans. The requirements of 
    Chapter 100 of Subtitle K of the Internal Revenue Code do not apply to 
    any group health plan for any plan year if, on the first day of the 
    plan year, the plan has fewer than 2 participants who are current 
    employees.
        (b) Excepted benefits--(1) In general. The requirements of 
    Secs. 54.9801-1T through 54.9801-6T and 54.9802-1T do not apply to any 
    group health plan in relation to its provision of the benefits 
    described in paragraph (b) (2), (3), (4), or (5) of this section (or 
    any combination of these benefits).
        (2) Benefits excepted in all circumstances. The following benefits 
    are excepted in all circumstances--
        (i) Coverage only for accident (including accidental death and 
    dismemberment);
        (ii) Disability income insurance;
        (iii) Liability insurance, including general liability insurance 
    and automobile liability insurance;
        (iv) Coverage issued as a supplement to liability insurance;
        (v) Workers' compensation or similar insurance;
        (vi) Automobile medical payment insurance;
        (vii) Credit-only insurance (for example, mortgage insurance); and
        (viii) Coverage for on-site medical clinics.
        (3) Limited excepted benefits--
        (i) In general. Limited-scope dental benefits, limited-scope vision 
    benefits, or long-term care benefits are excepted if they are provided 
    under a separate policy, certificate, or contract of insurance, or are 
    otherwise not an integral part of the plan, as defined in paragraph 
    (b)(3)(ii) of this section.
        (ii) Integral. For purposes of paragraph (b)(3)(i) of this section, 
    benefits are deemed to be an integral part of a plan unless a 
    participate has the right to elect not to receive coverage for the 
    benefits and, if the participant elects to receive coverage for the 
    benefits, the participant pays an additional premium or contribution 
    for that coverage.
        (iii) Limited scope. Limited scope dental or vision benefits are 
    dental or vision benefits that are sold under a separate policy or 
    rider and that are limited in scope in a narrow range or type of 
    benefits that are generally excluded from hospital/medical/surgical 
    benefit packages.
        (iv) Long-term care. Long-term care benefits are benefits that are 
    either--
        (A) Subject to State long-term care insurance laws;
        (B) For qualified long-term care insurance services; as defined in 
    section 7702B(c)(1) of the Internal Revenue Code, or provided under a 
    qualified long-term care insurance contract, as defined in section 
    7702B(b); or
        (C) Based on cognitive impairment or a loss of functional capacity 
    that is expected to be chronic.
        (4) Noncoordinated benefits--(i) Excepted benefits that are not 
    coordinated. Covered for only a specified disease or illness (for 
    example, cancer-only policies) or hospital indemnity or other fixed 
    dollar indemnity insurance (for example, $100/day) is excepted only if 
    it meets each of the conditions specified in paragraph (b)(4)(ii) of 
    this section.
        (ii) Conditions. Benefits are described in paragraph (b)(4)(i) of 
    this section only if--
        (A) The benefits are provided under a separate policy, certificate, 
    or contract of insurance;
        (B) There is not coordination between the provision of the benefits 
    and an exclusion of benefits under any group health plan maintained by 
    the same plan sponsor; and
        (C) The benefits are paid with respect to an event without regard 
    to whether benefits are provided with respect to the
    
    [[Page 16940]]
    
    event under any group health plan maintained by the same plan sponsor.
        (5) Supplemental benefits. The following benefits are excepted only 
    if they are provided under a separate policy, certificate, or contract 
    of insurance--
        (i) Medicare supplemental health insurance (as defined under 
    section 1882(g)(1) of the Social Security Act; also known as Medigap or 
    MedSupp insurance);
        (ii) Coverage supplemental to the coverage provided under Chapter 
    55, Title 10 of the United States Code (also known as CHAMPUS 
    supplemental programs); and
        (iii) Similar supplemental coverage provided to coverage under a 
    group health plan.
        (c) Treatment of partnerships. [Reserved]
    
    
    Sec. 54.9806-1T  Effective dates (temporary).
    
        (a) General effective dates--(1) Non-collectively-bargained plans. 
    Except as otherwise provided in this section, Chapter 100 of Subtitle K 
    of the Internal Revenue Code and Secs. 54.9801-1T through 54.9804-1T 
    apply with respect to group health plans for plan years beginning after 
    June 30, 1997.
        (2) Collectively bargained plans. Except as otherwise provided in 
    this section (other than paragraph (a)(1) of this section), in the case 
    of a group health plan maintained pursuant to one or more collective 
    bargaining agreements between employee representatives and one or more 
    employers ratified before August 21, 1996, Chapter 100 of Subtitle K of 
    the Internal Revenue Code and Secs. 54.9801-1T through 54.9804-1T do 
    not apply to plan years beginning before the later of July 1, 1997, or 
    the date on which the last of the collective bargaining agreements 
    relating to the plan terminates (determined without regard to any 
    extension thereof agreed to after August 21, 1996). For these purposes, 
    any plan amendment made pursuant to a collective bargaining agreement 
    relating to the plan, that amends the plan solely to conform to any 
    requirement of such part, is not treated as a termination of the 
    collective bargaining agreement.
        (3)(i) Preexisting condition exclusion periods for current 
    employees. Any preexisting condition exclusion period permitted under 
    Sec. 54.9801-3T is measured from the individual's enrollment date in 
    the plan. Such exclusion period, as limited under Sec. 54.9801-3T, may 
    be completed prior to the effective date of the Health Insurance 
    Portability and Accountability Act of 1996 (HIPAA) for his or her plan. 
    Therefore, on the date the individual's plan becomes subject to Chapter 
    100 of Subtitle K of the Internal Revenue Code, no preexisting 
    condition exclusion may be imposed with respect to an individual beyond 
    the limitation in Sec. 54.9801-3T. For an individual who has not 
    completed the permitted exclusion period under HIPPA, upon the 
    effective date for his or her plan, the individual may use creditable 
    coverage that the individual had prior to the enrollment date to reduce 
    the remaining preexisting condition exclusion period applicable to the 
    individual.
        (ii) Examples. The following examples illustrate the rules of this 
    paragraph (a)(3):
    
        Example 1. (i) Individual A has been working for Employer X and 
    has been covered under Employer X's plan since March 1, 1997. Under 
    Employer X's plan, as in effect before January 1, 1998, there is no 
    coverage for any preexisting condition. Employer X's plan year 
    begins on January 1, 1998. A's enrollment date in the plan is March 
    1, 1997 and A has no creditable coverage before this date.
        (ii) In this Example 1, Employer X may continue to impose the 
    preexisting condition exclusion under the plan through February 28, 
    1998 (the end of the 12-month period using anniversary dates).
         Example 2. (i) Same facts as in Example 1, except that A's 
    enrollment date was August 1, 1996, instead of March 1, 1997.
        (ii) In this Example 2, on January 1, 1998, Employer X's plan 
    may no longer exclude treatment for any preexisting condition that A 
    may have; however, because Employer X's plan is not subject to HIPAA 
    until January 1, 1998, A is not entitled to claim reimbursement for 
    expenses under the plan for treatments for any preexisting condition 
    of A received before January 1, 1998.
    
        (b) Effective date for certification requirement--(1) In general. 
    Subject to the transitional rule in Sec. 54.9801-5T(a)(5)(iii), the 
    certification rules of Sec. 54.9801-5T apply to events occurring on or 
    after July 1, 1996.
        (2) Period covered by certificate. A certificate is not required to 
    reflect coverage before July 1, 1996.
        (3) No certificate before June 1, 1997. Notwithstanding any other 
    provision of Sec. 54.9801-5T, in no case is a certificate required to 
    be provided before June 1, 1997.
        (c) Limitation on actions. No enforcement action is to be taken, 
    pursuant to Chapter 100 of Subtitle K of the Internal Revenue Code, 
    against a group health plan or health insurance issuer with respect to 
    a violation of a requirement imposed by Chapter 100 of Subtitle K of 
    the Internal Revenue Code before January 1, 1998 if the plan or issuer 
    has sought to comply in good faith with such requirements. Compliance 
    with these regulations is deemed to be good faith compliance with the 
    requirements of Chapter 100 of Subtitle K.
        (d) Transition rules for counting creditable coverage. An 
    individual who seeks to establish creditable coverage for periods 
    before July 1, 1996 is entitled to establish such coverage through the 
    presentation of documents or other means in accordance with the 
    provisions of Sec. 54.9801-5T(c). For coverage relating to an event 
    occurring before July 1, 1996, a group health plan and a health 
    insurance issuer is not subject to any penalty or enforcement action 
    with respect to the plan's or issuer's counting (or not counting) such 
    coverage if the plan or issuer has sought to comply in good faith with 
    the applicable requirements under Sec. 54.9801-5T(c).
        (e) Transition rules for certificates of creditable coverage--(1) 
    Certificates only upon request. For events occurring on or after July 
    1, 1996 but before October 1, 1996, a certificate is required to be 
    provided only upon a written request by or on behalf of the individual 
    to whom the certificate applies.
        (2) Certificates before June 1, 1997. For events occurring on or 
    after October 1, 1996 and before June 1, 1997, a certificate must be 
    furnished no later than June 1, 1997, or any later date permitted under 
    Sec. 54.9801-5T(a)(2) (ii) and (iii).
        (3) Optional notice--(i) In general. This paragraph (e)(3) applies 
    with respect to events described in Sec. 54.9801-5T(a)(5)(ii), that 
    occur on or after October 1, 1996 but before June 1, 1997. A group 
    health plan or health insurance issuer offering group health coverage 
    is deemed to satisfy Sec. 54.9801-5T(a) (2) and (3) if a notice is 
    provided in accordance with the provisions of paragraphs (e)(3) (i) 
    through (iv) of this section.
        (ii) Time of notice. The notice must be provided no later than June 
    1, 1997.
        (iii) Form and content of notice. A notice provided pursuant to 
    this paragraph (e)(3) must be in writing and must include information 
    substantially similar to the information included in a model notice 
    authorized by the Secretary. Copies of the model notice are available 
    at the following website--http://www.irs.ustreas.gov (or call (202) 
    622-4695).
        (iv) Providing certificate after request. If an individual requests 
    a certificate following receipt of the notice, the certificate must be 
    provided at the time of the request as set forth in Sec. 54.9801-
    5T(a)(5)(iii).
        (v) Other certification rules apply. The rules set forth in 
    Sec. 54.9801-5T(a)(4)(i) (method of delivery) and
    
    [[Page 16941]]
    
    54.9801-5T(a)(1) (entities required to provide a certificate) apply 
    with respect to the provision of the notice.
    
        Dated: March 24, 1997.
    Margaret Milner Richardson,
    Commissioner of Internal Revenue.
    
        Approved:
    Donald C. Lubick,
    Assistant Secretary of the Treasury.
    
    Pension and Welfare Benefits Administration
    
    29 CFR Chapter XXV
    
        For the reasons set forth above, Chapter XXV of Title 29 of the 
    Code of Federal Regulations is amended as set forth below:
        1. A new Subchapter L, consisting of Part 2590, is added to read as 
    follows:
    Subchapter L--Health Insurance Portability and Renewability for Group 
    Health Plans
    
    PART 2590--RULES AND REGULATIONS FOR HEALTH INSURANCE PORTABILITY 
    AND RENEWABILITY FOR GROUP HEALTH PLANS
    
    Subpart A--Requirements Relating to Access and Renewability of 
    Coverage, and Limitation on Preexisting Condition Exclusion Periods
    Sec.
    2590.701-1  Basis and scope.
    2590.701-2  Definitions.
    2590.701-3  Limitations on preexisting condition exclusion period.
    2590.701-4  Rules relating to creditable coverage.
    2590.701-5  Certification and disclosure of previous coverage.
    2590.701-6  Special enrollment periods.
    2590.701-7  HMO affiliation period as alternative to preexisting 
    condition exclusion.
    2590.702  Prohibiting discrimination against participants and 
    beneficiaries based on a health status-related factor.
    2590.703  Guaranteed renewability in multiemployer plans and 
    multiple employer welfare arrangements. [Reserved]
    
    Subpart B--Other Requirements
    
    2590.711  Standards relating to benefits for mothers and newborns. 
    [Reserved]
    2590.712  Parity in the application of certain limits to mental 
    health benefits. [Reserved]
    
    Subpart C--General Provisions
    
    2590.731  Preemption; State flexibility; construction.
    2590.732  Special rules relating to group health plans.
    2590.734  Enforcement. [Reserved]
    2590.736  Effective dates.
    
        Authority: Sec. 29 U.S.C. 1027, 1059, 1135, 1171, 1194; Sec. 
    101, Pub. L. 104-191, 101 Stat. 1936 (29 U.S.C. 1181); Secretary of 
    labor's Order No. 1-87, 52 FR 13139, April 21, 1987.
    
    Subpart A--Requirements Relating to Access and Renewability of 
    Coverage, and Limitations on Preexisting Condition Exclusion 
    Periods
    
    
    Sec. 2590.701-1  Basis and scope.
    
        (a) Statutory basis. This subpart implements Part 7 of Subtitle B 
    of Title I of the Employee Retirement Income Security Act of 1974, as 
    amended (hereinafter ERISA or the Act).
        (b) Scope. A group health plan or health insurance issuer offering 
    group health insurance coverage may provide greater rights to 
    participants and beneficiaries than those set forth in this subpart. 
    This subpart A sets forth minimum requirements for group health plans 
    and health insurance issuers offering group health insurance coverage 
    concerning:
        (1) Limitations on a preexisting condition exclusion period.
        (2) Certificates and disclosure of previous coverage.
        (3) Rules relating to counting creditable coverage.
        (4) Special enrollment periods.
        (5) Use of an affiliation period by an HMO as an alternative to a 
    preexisting condition exclusion.
    
    
    Sec. 2590.701-2  Definitions.
    
        Unless otherwise provided, the definitions in this section govern 
    in applying the provisions of Secs. 2590.701 through 2590.734.
        Affiliation period means a period of time that must expire before 
    health insurance coverage provided by an HMO becomes effective, and 
    during which the HMO is not required to provide benefits.
        COBRA definitions:
        (1) COBRA means Title X of the Consolidated Omnibus Budget 
    Reconciliation Act of 1985, as amended.
        (2) COBRA continuation coverage means coverage, under a group 
    health plan, that satisfies an applicable COBRA continuation provision.
        (3) COBRA continuation provision means sections 601-608 of the Act, 
    section 4980B of the Code (other than paragraph (f)(1) of such section 
    4980B insofar as it relates to pediatric vaccines), and Title XXII of 
    the PHSA.
        (4) Exhaustion of COBRA continuation coverage means that an 
    individual's COBRA continuation coverage ceases for any reason other 
    than either failure of the individual to pay premiums on a timely 
    basis, or for cause (such as making a fraudulent claim or an 
    intentional misrepresentation of a material fact in connection with the 
    plan). An individual is considered to have exhausted COBRA continuation 
    coverage if such coverage ceases--
        (i) Due to the failure of the employer or other responsible entity 
    to remit premiums on a timely basis; or
        (ii) When the individual no longer resides, lives, or works in a 
    service area of an HMO or similar program (whether or not within the 
    choice of the individual) and there is no other COBRA continuation 
    coverage available to the individual.
        Condition means a medical condition.
        Creditable coverage means creditable coverage within the meaning of 
    Sec. 2590.701-4(a).
        Enroll means to become covered for benefits under a group health 
    plan (i.e., when coverage becomes effective), without regard to when 
    the individual may have completed or filed any forms that are required 
    in order to enroll in the plan. For this purpose, an individual who has 
    health insurance coverage under a group health plan is enrolled in the 
    plan regardless of whether the individual elects coverage, the 
    individual is a dependent who becomes covered as a result of an 
    election by a participant, or the individual becomes covered without an 
    election.
        Enrollment date definitions (enrollment date and first day of 
    coverage) are set forth in Sec. 2590.701-3(a)(2) (i) and (ii).
        Excepted benefits means the benefits described as excepted in 
    Sec. 2590.732(b).
        Genetic information means information about genes, gene products, 
    and inherited characteristics that may derive from the individual or a 
    family member. This includes information regarding carrier status and 
    information derived from laboratory tests that identify mutations in 
    specific genes or chromosomes, physical medical examinations, family 
    histories, and direct analysis of genes or chromosomes.
        Group health insurance coverage means health insurance coverage 
    offered in connection with a group health plan.
        Group health plan means an employee welfare benefit plan to the 
    extent that the plan provides medical care (including items and 
    services paid for as medical care) to employees or their dependents (as 
    defined under the terms of the plan) directly or through insurance, 
    reimbursement, or otherwise.
        Group market means the market for health insurance coverage offered 
    in connection with a group health plan. (However, certain very small 
    plans may be treated as being in the individual market, rather than the 
    group market; see the definition of individual market in this section.)
        Health insurance coverage means benefits consisting of medical care 
    (provided directly, through insurance or
    
    [[Page 16942]]
    
    reimbursement, or otherwise) under any hospital or medical service 
    policy or certificate, hospital or medical service plan contract, or 
    HMO contract offered by a health insurance issuer.
        Health insurance issuer or issuer means an insurance company, 
    insurance service, or insurance organization (including an HMO) that is 
    required to be licensed to engage in the business of insurance in a 
    State and that is subject to State law that regulates insurance (within 
    the meaning of section 514(b)(2) of the Act). Such term does not 
    include a group health plan.
        Health maintenance organization or HMO means--
        (1) A federally qualified health maintenance organization (as 
    defined in section 1301(a) of the PHSA);
        (2) An organization recognized under State law as a health 
    maintenance organization; or
        (3) A similar organization regulated under State law for solvency 
    in the same manner and to the same extent as such a health maintenance 
    organization.
        Individual health insurance coverage means health insurance 
    coverage offered to individuals in the individual market, but does not 
    include short-term, limited duration insurance. For this purpose, 
    short-term, limited-duration insurance means health insurance coverage 
    provided pursuant to a contract with an issuer that has an expiration 
    date specified in the contract (taking into account any extensions that 
    may be elected by the policyholder without the issuer's consent) that 
    is within 12 months of the date such contract becomes effective. 
    Individual health insurance coverage can include dependent coverage.
        Individual market means the market for health insurance coverage 
    offered to individuals other than in connection with a group health 
    plan. Unless a State elects otherwise in accordance with section 
    2791(e)(1)(B)(ii) of the PHSA, such term also includes coverage offered 
    in connection with a group health plan that has fewer than two 
    participants as current employees on the first day of the plan year.
        Internal Revenue Code (Code) means the Internal Revenue Code of 
    1986, as amended (Title 26, United States Code).
        Issuer means a health insurance issuer.
        Late enrollment definitions (late enrollee) and late enrollment) 
    are set forth in Sec. 2590.701-3(a)(2) (iii) and (iv).
        Medical care means amounts paid for--
        (1) The diagnosis, cure, mitigation, treatment, or prevention of 
    disease, or amounts paid for the purpose of affecting any structure or 
    function of the body;
        (2) Transportation primarily for and essential to medical care 
    referred to in paragraph (1) of this definition; and
        (3) Insurance covering medical care referred to in paragraphs (1) 
    and (2) of this definition.
        Medical condition or condition means any condition, whether 
    physical or mental, including, but not limited to, any condition 
    resulting from illness, injury (whether or not the injury is 
    accidental), pregnancy, or congenital malformation. However, genetic 
    information is not a condition.
        Placement, or being placed, for adoption means the assumption and 
    retention of a legal obligation for total or partial support of a child 
    by a person with whom the child has been placed in anticipation of the 
    child's adoption. The child's placement for adoption with such person 
    terminates upon the termination of such legal obligation.
        Plan year means the year that is designated as the plan year in the 
    plan document of a group health plan, except that if the plan document 
    does not designate a plan year or if there is no plan document, the 
    plan year is--
        (1) The deductible/limit year used under the plan;
        (2) If the plan does not impose deductibles or limits on a yearly 
    basis, then the plan year is the policy year;
        (3) If the plan does not impose deductibles or limits on a yearly 
    basis, and either the plan is not insured or the insurance policy is 
    not renewed on an annual basis, then the plan year is the employer's 
    taxable year; or
        (4) In any other case, the plan year is the calendar year.
        Preexisting condition exclusion means a limitation or exclusion of 
    benefits relating to a condition based on the fact that the condition 
    was present before the first day of coverage, whether or not any 
    medical advice, diagnosis, care, or treatment was recommended or 
    received before that day. A preexisting condition exclusion includes 
    any exclusion applicable to an individual as a result of information 
    that is obtained relating to an individual's health status before the 
    individual's first day of coverage, such as a condition identified as a 
    result of a pre-enrollment questionnaire or physical examination given 
    to the individual, or review of medical records relating to the pre-
    enrollment period.
        Public health plan means public health plan within the meaning of 
    Sec. 2590.701-4(a)(1)(ix).
        Public Health Service Act (PHSA) means the Public Health Service 
    Act (42 U.S.C. 201, et seq.).
        Significant break in coverage means a significant break in coverage 
    within the meaning of Sec. 2590.701-4(b)(2)(iii).
        Special enrollment date means a special enrollment date within the 
    meaning of Sec. 2590.701-6(d).
        State means each of the several States, the District of Columbia, 
    Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern 
    Mariana Islands.
        State health benefits risk pool means a State health benefits risk 
    pool within the meaning of Sec. 2590.701-4(a)(1)(vii).
        Waiting period means the period that must pass before an employee 
    or dependent is eligible to enroll under the terms of a group health 
    plan. If an employee or dependent enrolls as a late enrollee or on a 
    special enrollment date, any period before such late or special 
    enrollment is not a waiting period. If an individual seeks and obtains 
    coverage in the individual market, any period after the date the 
    individual files a substantially complete application for coverage and 
    before the first day of coverage is a waiting period.
    
    
    Sec. 2590.701-3  Limitations on preexisting condition exclusion period.
    
        (a) Preexisting condition exclusion--(1) In general. Subject to 
    paragraph (b) of this section, a group health plan, and a health 
    insurance issuer offering group health insurance coverage, may impose, 
    with respect to a participant or beneficiary, a preexisting condition 
    exclusion only if the requirements of this paragraph (a) are satisfied.
        (i) 6-month look-back rule. A preexisting condition exclusion must 
    relate to a condition (whether physical or mental), regardless of the 
    cause of the condition, for which medical advice, diagnosis, care, or 
    treatment was recommended or received within the 6-month period ending 
    on the enrollment date.
        (A) For purposes of this paragraph (a)(1)(i), medical advice, 
    diagnosis, care, or treatment is taken into account only if it is 
    recommended by, or received from, an individual licensed or similarly 
    authorized to provide such services under State law and operating 
    within the scope of practice authorized by State law.
        (B) For purposes of this paragraph (a)(1)(i), the 6-month period 
    ending on the enrollment date begins on the 6-month anniversary date 
    preceding the enrollment date. For example, for an enrollment date of 
    August 1, 1998, the 6-month period preceding the enrollment date is the 
    period commencing on February 1, 1998 and continuing through July 31, 
    1998. As another example, for an enrollment date
    
    [[Page 16943]]
    
    of August 30, 1998, the 6-month period preceding the enrollment date is 
    the period commencing on February 28, 1998 and continuing through 
    August 29, 1998.
        (C) The rules of this paragraph (a)(1)(i) are illustrated by the 
    following examples:
    
        Example 1. (i) Individual A is treated for a medical condition 7 
    months before the enrollment date in Employer R's group health plan. 
    As part of such treatment, A's physician recommends that a follow-up 
    examination be given 2 months later. Despite this recommendation. A 
    does not receive a follow-up examination and no other medical 
    advice, diagnosis, care, or treatment for that condition is 
    recommended to A or received by A during the 6-month period ending 
    on A's enrollment date in Employer R's plan.
        (ii) In this Example 1, Employer R's plan may not impose a 
    preexisting condition exclusion period with respect to the condition 
    for which A received treatment 7 months prior to the enrollment 
    date.
        Example 2. (i) Same facts as Example 1, except that Employer R's 
    plan learns of the condition and attaches a rider to A's policy 
    excluding coverage for the condition. Three months after enrollment, 
    A's condition recurs, and Employer R's plan denies payment under the 
    rider.
        (ii) In this Example 2, The rider is preexisting condition 
    exclusion and Employer R's plan may not impose a preexisting 
    condition exclusion with respect to the condition for which A 
    received treatment 7 months prior to the enrollment date.
        Example 3. (i) Individual B has asthma and is treated for that 
    condition several times during the 6-month period before B's 
    enrollment date in Employer S's plan. The plan imposes a 12-month 
    preexisting condition exclusion. B has no prior creditable coverage 
    to reduce the exclusion period. Three months after the enrollment 
    date, B begins coverage under Employer S's plan. Two months later, B 
    is hospitalized asthma.
        (ii) In this Example 3, Employer S's plan may exclude payment 
    for the hospital stay and the physician services associated with 
    this illness because the care is related to a medical condition for 
    which treatment was received by B during the 6-month period before 
    the enrollment date.
        Example 4. (i) Individual D, who is subject to a preexisting 
    exclusion imposed by Employer U's plan, has diabetes, as well as a 
    foot condition caused by poor circulation and retinal degeneration 
    (both of which are conditions that may be directly attributed to 
    diabetes). After enrolling in the plan, D stumbles and breaks a leg.
        (ii) In this Example 4, the leg is fracture is not a condition 
    related to D's diabetes, even though poor circulation in D's 
    extremities and poor vision may have contributed towards the 
    accident. However, any additional medical services that may be 
    needed because of D's preexisting diabetic condition that would not 
    be needed by another patient with a broken leg who does not have 
    diabetes may be subject to the preexisting condition exclusion 
    imposed under Employer U's plan.
    
        (ii) Maximum length of preexisting condition exclusion (the look-
    forward rule). A preexisting condition exclusion is not permitted to 
    extend for more than 12 months (18 months in the case of a late 
    enrollee) after the enrollment date. For purposes of this paragraph 
    (a)(1)(ii), the 12-month and 18-month periods after the enrollment date 
    are determined by reference to the anniversary of the enrollment date. 
    For example, for an enrollment date of August 1, 1998, the 12-month 
    period after the enrollment date is the period commencing on August 1, 
    1998 and continuing through July 31, 1999.
        (iii) Reducing a preexisting condition exclusion period by 
    creditable coverage. The period of any preexisting condition exclusion 
    that would otherwise apply to an individual under a group health plan 
    is reduced by the number of days of creditable coverage the individual 
    has as of the enrollment date, as counted under Sec. 2590.701-4. For 
    purposes of this subpart the phrase ``days of creditable coverage'' has 
    the same meaning as the phrase ``aggregate of the periods of creditable 
    coverage'' as such term is used in section 701(a)(3) of the Act.
        (iv) Other Standards. See Sec. 2590.702 for other standards that 
    may apply with respect to certain benefits limitations or restrictions 
    under a group health plan.
        (2) Enrollment definitions--(i) Enrollment date means the first day 
    of coverage or, if there is a waiting period, the first day of the 
    waiting period.
        (ii)(A) First day of coverage means, in the case of an individual 
    covered for benefits under a group health plan in the group market, the 
    first day of coverage under the plan and, in the case of an individual 
    covered by health insurance coverage in the individual market, the 
    first day of coverage under the policy.
        (B) The following example illustrates the rule of paragraph 
    (a)(2)(ii)(A) of this section:
    
        Example. (i) Employer V's group health plan provides for 
    coverage to begin on the first day of the first payroll period 
    following the date an employee is hired and completes the applicable 
    enrollment forms, or on any subsequent January 1 after completion of 
    the applicable enrollment forms. Employer's V's plan imposes a 
    preexisting condition exclusion for 12 months (reduced by the 
    individual's creditable coverage) following an individual's 
    enrollment date. Employee E is hired by Employer V on October 13, 
    1998 and then on October 14, 1998 completes and files all the forms 
    necessary to enroll in the plan. E's coverage under the plan becomes 
    effective on October 25, 1998 (which is the beginning of the first 
    payroll period after E's date of hire).
        (ii) In this Example, E's enrollment date is October 13, 1998 
    (which is the first day of the waiting period for E's enrollment and 
    is also E's date of hire). Accordingly, with respect to E, the 6-
    month period in paragraph (a)(1)(i) would be the period from April 
    13, 1998 through October 12, 1998, the maximum permissible period 
    during which Employer V's plan could apply a preexisting condition 
    exclusion under paragraph (a)(1)(ii) would be in the period from 
    October 13, 1998 through October 12, 1999, and this period would be 
    reduced under paragraph (a)(1)(iii) by E's days of creditable 
    coverage as of October 13, 1998.
    
        (iii) Late enrollee means an individual whose enrollment in a plan 
    is a late enrollment.
        (iv)(A) Late enrollment means enrollment under a group health plan 
    other than on--
        (1) The earliest date on which coverage can become effective under 
    the terms of the plan; or
        (2) A special enrollment date for the individual.
        (B) If an individual ceases to be eligible for coverage under the 
    plan by terminating employment, and then subsequently becomes eligible 
    for coverage under the plan by resuming employment, only eligibility 
    during the individual's most recent period of employment is taken into 
    account in determining whether the individual is a late enrollee under 
    the plan with respect to the most recent period of coverage. Similar 
    rules apply if an individual again becomes eligible for coverage 
    following a suspension of coverage that applied generally under the 
    plan.
        (v) Examples. The rules of this paragraph (a)(2) are illustrated by 
    the following examples:
    
        Example 1. (i) Employee F first becomes eligible to be covered 
    by Employer W's group health plan on January 1, 1999, but elects not 
    to enroll in the plan until April 1, 1999. April 1, 1999 is not a 
    special enrollment date for F.
        (ii) In this Example 1, F would be a late enrollee with respect 
    to F's coverage that became effective under the plan on April 1, 
    1999.
        Example 2. (i) Same as Example 1, except that F does not enroll 
    in the plan on April 1, 1999 and terminates employment with Employer 
    W on July 1, 1999, without having had any health insurance coverage 
    under the plan. F is rehired by Employer W on January 1, 2000 and is 
    eligible for and elects coverage under Employer W's plan effective 
    on January 1, 2000.
        (ii) In this Example 2, F would not be a late enrollee with 
    respect to F's coverage that became effective on January 1, 2000.
    
        (b) Exceptions pertaining to preexisting condition exclusions--(1) 
    Newborns--(i) In general. Subject to
    
    [[Page 16944]]
    
    paragraph (b)(3) of this section, a group health plan, and a health 
    insurance issuer offering group health insurance coverage, may not 
    impose any preexisting condition exclusion with regard to a child who, 
    as of the last day of the 30-day period beginning with the date of 
    birth, is covered under any creditable coverage. Accordingly, if a 
    newborn is enrolled in a group health plan (or other creditable 
    coverage) within 30 days after birth and subsequently enrolls in 
    another group health plan without a significant break in coverage, the 
    other plan may not impose any preexisting condition exclusion with 
    regard to the child.
        (ii) Example. The rule of this paragraph (b)(1) is illustrated by 
    the following example:
    
        Example. (i) Seven months after enrollment in Employer W's group 
    health plan, Individual E has a child born with a birth defect. 
    Because the child is enrolled in Employer W's plan within 30 days of 
    birth, no preexisting condition exclusion may be imposed with 
    respect to the child under Employer W's plan. Three months after the 
    child's birth, E, commences employment with Employer X and enrolls 
    with the child in Employer X's plan 45 days after leaving Employer 
    W's plan. Employer X's plan imposes a 12-month exclusion for any 
    preexisting condition.
        (ii) In this Example, Employer X's plan may not impose any 
    preexisting condition exclusion with respect to E's child because 
    the child was covered within 30 days of birth and had no significant 
    break in coverage. This result applies regardless of whether E's 
    child is included in the certificate of creditable coverage provided 
    to E by Employer W indicating 300 days of dependent coverage or 
    receives a separate certificate indicating 90 days of coverage. 
    Employer X's plan may impose a preexisting condition exclusion with 
    respect to E for up to 2 months for any preexisting condition of E 
    for which medical advice, diagnosis, care, or treatment was 
    recommended or received by E within the 6-month period ending on E's 
    enrollment date in Employer X's plan.
    
        (2) Adopted children. Subject to paragraph (b)(3) of this section, 
    a group health plan, and a health insurance issuer offering group 
    health insurance coverage, may not impose any preexisting condition 
    exclusion in the case of a child who is adopted or placed for adoption 
    before attaining 18 years of age and who, as of the last day of the 30-
    day period beginning on the date of the adoption or placement for 
    adoption, is covered under creditable coverage. This rule does not 
    apply to coverage before the date of such adoption or placement for 
    adoption.
        (3) Break in coverage. Paragraphs (b) (1) and (2) of this section 
    no longer apply to a child after a significant break in coverage.
        (4) Pregnancy. A group health plan, and a health insurance issuer 
    offering group health insurance coverage, may not impose a preexisting 
    condition exclusion relating to pregnancy as a preexisting condition.
        (5) Special enrollment dates. For special enrollment dates relating 
    to new dependents, see Sec. 2590.701-6(b).
        (c) Notice of plan's preexisting condition exclusion. A group 
    health plan, and health insurance issuer offering group health 
    insurance under the plan, may not impose a preexisting condition 
    exclusion with respect to a participant or dependent of the participant 
    before notifying the participant, in writing, of the existence and 
    terms of any preexisting condition exclusion under the plan and of the 
    rights of individuals to demonstrate creditable coverage (and any 
    applicable waiting periods) as required by Sec. 2590.701-5. The 
    description of the rights of individuals to demonstrate creditable 
    coverage includes a description of the right of the individual to 
    request a certificate from a prior plan or issuer, if necessary, and a 
    statement that the current plan or issuer will assist in obtaining a 
    certificate from any prior plan or issuer, if necessary.
    
    
    Sec. 2590.701-4  Rules relating to creditable coverage.
    
        (a) General rules--
        (1) Creditable coverage. For purposes of this section, except as 
    provided in paragraph (a)(2) of this section, the term creditable 
    coverage means coverage of an individual under any of the following:
        (i) A group health plan as defined in Sec. 2590.701-2.
        (ii) Health insurance coverage as defined in Sec. 2590.701-2 
    (whether or not the entity offering the coverage is subject to Part 7 
    of Subtitle B of Title I of the Act, and without regard to whether the 
    coverage is offered in the group market, the individual market, or 
    otherwise).
        (iii) Part A or B of Title XVIII of the Social Security Act 
    (Medicare).
        (iv) Title XIX of the Social Security Act (Medicaid), other than 
    coverage consisting solely of benefits under section 1928 of the Social 
    Security Act (the program for distribution of pediatric vaccines).
        (v) Title 10 U.S.C. Chapter 55 (medical and dental care for members 
    and certain former members of the uniformed services, and for their 
    dependents; for purposes of Title 10 U.S.C. Chapter 55, uniformed 
    services means the armed forces and the Commissioned Corps of the 
    National Oceanic and Atmospheric Administration and of the Public 
    Health Service).
        (vi) A medical care program of the Indian Health Service or of a 
    tribal organization.
        (vii) A State health benefits risk pool. For purposes of this 
    section, a State health benefits risk pool means--
        (A) An organization qualifying under section 501(c)(26) of the 
    Code;
        (B) A qualified high risk pool described in section 2744(c)(2) of 
    the PHSA; or
        (C) Any other arrangement sponsored by a State, the membership 
    composition of which is specified by the State and which is established 
    and maintained primarily to provide health insurance coverage for 
    individuals who are residents of such State and who, by reason of the 
    existence or history of a medical condition--
        (1) Are unable to acquire medical care coverage for such condition 
    through insurance or from an HMO, or
        (2) Are able to acquire such coverage only at a rate which is 
    substantially in excess of the rate for such coverage through the 
    membership organization.
        (viii) A health plan offered under Title 5 U.S.C. Chapter 89 (the 
    Federal Employees Health Benefits Program).
        (ix) A public health plan. For purposes of this section, a public 
    health plan means any plan established or maintained by a State, 
    county, or other political subdivision of a State that provides health 
    insurance coverage to individuals who are enrolled in the plan.
        (x) A health benefit plan under section 5(e) of the Peace Corps Act 
    (22 U.S.C. 2504(e)).
        (2) Excluded coverage. Creditable coverage does not include 
    coverage consisting solely of coverage of excepted benefits (described 
    in Sec. 2590.732).
        (3) Methods of counting creditable coverage. For purposes of 
    reducing any preexisting condition exclusion period, as provided under 
    Sec. 2590.701-3(a)(1)(iii), a group health plan, and a health insurance 
    issuer offering group health insurance coverage, determines the amount 
    of an individual's creditable coverage by using the standard method 
    described in paragraph (b) of this section, except that the plan, or 
    issuer, may use the alternative method under paragraph (c) of this 
    section with respect to any or all of the categories of benefits 
    described under paragraph (c)(3) of this section.
        (b) Standard method--(1) Specific benefits not considered. Under 
    the standard method, a group health plan, and a health insurance issuer 
    offering group health insurance coverage, determines the amount of 
    creditable
    
    [[Page 16945]]
    
    coverage without regard to the specific benefits included in the 
    coverage.
        (2) Counting creditable coverage--(i) Based on days. For purposes 
    of reducing the preexisting condition exclusion period, a group health 
    plan, and a health insurance issuer offering group health insurance 
    coverage, determines the amount of creditable coverage by counting all 
    the days that the individual has under one or more types of creditable 
    coverage. Accordingly, if on a particular day, an individual has 
    creditable coverage from more than one source, all the creditable 
    coverage on that day is counted as one day. Further, any days in a 
    waiting period for a plan or policy are not creditable coverage under 
    the plan or policy.
        (ii) Days not counted before significant break in coverage. Days of 
    creditable coverage that occur before a significant break in coverage 
    are not required to be counted.
        (iii) Definition of significant break in coverage. A significant 
    break in coverage means a period of 63 consecutive days during all of 
    which the individual does not have any creditable coverage, except that 
    neither a waiting period nor an affiliation period is taken into 
    account in determining a significant break in coverage. (See section 
    731(b)(2)(iii) of the Act and section 2723(b)(2)(iii) of the PHSA which 
    exclude from preemption State insurance laws that require a break of 
    more than 63 days before an individual has a significant break in 
    coverage for purposes of State law.)
        (iv) Examples. The following examples illustrate how creditable 
    coverage is counted in reducing preexisting condition exclusion periods 
    under this paragraph (b)(2):
    
        Example 1. (i) Individual A works for Employer P and has 
    creditable coverage under Employer P's plan for 18 months before A's 
    employment terminates. A is hired by Employer Q, and enrolls in 
    Employer Q's group health plan, 64 days after the last date of 
    coverage under Employer P's plan. Employer Q's plan has a 12-month 
    preexisting condition exclusion period.
        (ii) In this Example 1, because A had a break in coverage of 63 
    days, Employer Q's plan may disregard A's prior coverage and A may 
    be subject to a 12-month preexisting condition exclusion period.
        Example 2. (i) Same facts as Example 1, except that A is hired 
    by Employer Q, and enrolls in Employer Q's plan, on the 63rd day 
    after the last date of coverage under Employer P's plan.
        (ii) In this Example 2, A has a break in coverage of 62 days. 
    Because A's break in coverage is not a significant break in 
    coverage, Employer Q's plan must count A's prior creditable coverage 
    for purposes of reducing the plan's preexisting condition exclusion 
    period as it applies to A.
        Example 3. (i) Same facts as Example 1, except that Employer Q's 
    plan provides benefits through an insurance policy that, as required 
    by applicable State insurance laws, defines a significant break in 
    coverage as 90 days.
        (ii) In this Example 3, the issuer that provides group health 
    insurance to Employer Q's plan must count A's period of creditable 
    coverage prior to the 63-day break.
        Example 4. (i) Same facts as Example 3, except that Employer Q's 
    plan is a self-insured plan, and, thus, is not subject to State 
    insurance laws.
        (ii) In this Example 4, the plan is not governed by the longer 
    break rules under State insurance law and A's previous coverage may 
    be disregarded.
        Example 5. (i) Individual B begins employment with Employer R 45 
    days after terminating coverage under a prior group health plan. 
    Employer R's plan has a 30-day waiting period before coverage 
    begins. B enrolls in Employer R's plan when first eligible.
        (ii) In this Example 5, B does not have a significant break in 
    coverage for purposes of determining whether B's prior coverage must 
    be counted by Employer R's plan. B has only a 44-day break in 
    coverage because the 30-day waiting period is not taken into account 
    in determining a significant break in coverage.
        Example 6, (i) Individual C works for Employer S and has 
    creditable coverage under Employer S's plan for 200 days before C's 
    employment is terminated and coverage ceases. C is then unemployed 
    for 51 days before being hired by Employer T. Employer T's plan has 
    a 3-month waiting period. C works for Employer T for 2 months and 
    then terminates employment. Eleven days after terminating employment 
    with Employer T, C begins working for Employer U. Employer U's plan 
    has no waiting period, but has a 6-month preexisting condition 
    exclusion period.
        (ii) In this Example 6, C does not have a significant break in 
    coverage because, after disregarding the waiting period under 
    Employer T's plan, C had only a 62-day break in coverage (51 days 
    plus 11 days). Accordingly, C has 200 days of creditable coverage 
    and Employer U's plan may not apply its 6-month preexisting 
    condition exclusion period with respect to C.
        Example 7. (i) Individual D terminates employment with Employer 
    V on January 13, 1998 after being covered for 24 months under 
    Employer V's group health plan. On March 17, the 63rd day without 
    coverage, D applies for a health insurance policy in the individual 
    market. D's application is accepted and the coverage is made 
    effective May 1.
        (ii) In this Example 7, because D applied for the policy before 
    the end of the 63rd day, and coverage under the policy ultimately 
    became effective, the period between the date of application and the 
    first day of coverage is a waiting period and no significant break 
    in coverage occurred even though the actual period without coverage 
    was 107 days.
        Example 8. (i) Same facts as Example 7, except that D's 
    application for a policy in the individual market is denied.
        (ii) In this Example 8, because D did not obtain coverage 
    following application, D incurred a significant break in coverage on 
    the 64th day.
    
        (v) Other permissible counting methods--(A) Rule. Notwithstanding 
    any other provisions of this paragraph (b)(2), for purposes of reducing 
    a preexisting condition exclusion period (but not for purposes of 
    issuing a certificate under Sec. 2590.701-5), a group health plan, and 
    a health insurance issuer offering group health insurance coverage, may 
    determine the amount of creditable coverage in any other manner that is 
    at least as favorable to the individual as the method set forth in this 
    paragraph (b)(2), subject to the requirements of other applicable law.
        (B) Example. The rule of this paragraph (b)(2)(v) is illustrated by 
    the following example:
    
        Example. (i) Individual F has coverage under group health plan Y 
    from January 3, 1997 through March 25, 1997. F then becomes covered 
    by group health plan Z. F's enrollment date in Plan Z is May 1, 
    1997. Plan Z has a 12-month preexisting condition exclusion period.
        (ii) In this Example, Plan Z may determine, in accordance with 
    the rules prescribed in paragraph (b)(2) (i), (ii), and (iii) of 
    this section, that F has 82 days of creditable coverage (29 days in 
    January, 28 days in February, and 25 days in March). Thus, the 
    preexisting condition exclusion period will no longer apply to F on 
    February 8, 1998 (82 days before the 12-month anniversary of F's 
    enrollment (May 1)). For administrative convenience, however, Plan Z 
    may consider that the preexisting condition exclusion period will no 
    longer apply to F on the first day of the month (February 1).
    
        (c) Alternative method--(1) Specific benefits considered. Under the 
    alternative method, a group health plan, or a health insurance issuer 
    offering group health insurance coverage, determines the amount of 
    creditable coverage based on coverage within any category of benefits 
    described in paragraph (c)(3) of this section and not based on coverage 
    for any other benefits. The plan or issuer may use the alternative 
    method for any or all of the categories. The plan may apply a different 
    preexisting condition exclusion period with respect to each category 
    (and may apply a different preexisting condition exclusion period for 
    benefits that are not within any category). The creditable coverage 
    determined for a category of benefits applies only for purposes of 
    reducing the preexisting condition exclusion period with respect to 
    that category. An individual's creditable coverage for benefits that 
    are not within any category for which the alternative method is being 
    used is determined under the
    
    [[Page 16946]]
    
    standard method of paragraph (b) of this section.
        (2) Uniform application. A plan or issuer using the alternative 
    method is required to apply it uniformly to all participants and 
    beneficiaries under the plan or policy. The use of the alternative 
    method is required to be set forth in the plan.
        (3) Categories of benefits. The alternative method for counting 
    creditable coverage may be used for coverage for the following 
    categories of benefits--
        (i) Mental health;
        (ii) Substance abuse treatment;
        (iii) Prescription drugs;
        (iv) Dental care; or
        (v) Vision care.
        (4) Plan notice. If the alternative method is used, the plan is 
    required to--
        (i) State prominently that the plan is using the alternative method 
    of counting creditable coverage in disclosure statements concerning the 
    plan, and state this to each enrollee at the time of enrollment under 
    the plan; and
        (ii) Include in these statements a description of the effect of 
    using the alternative method, including an identification of the 
    categories used.
        (5) Disclosure of information on previous benefits. See 
    Sec. 2590.701-5(b) for special rules concerning disclosure of coverage 
    to a plan, or issuer, using the alternative method of counting 
    creditable coverage under this paragraph (c).
        (6) Counting creditable coverage--(i) In general. Under the 
    alternative method, the group health plan or issuer counts creditable 
    coverage within a category if any level of benefits is provided within 
    the category. Coverage under a reimbursement account or arrangement, 
    such as a flexible spending arrangement (as defined in section 
    106(c)(2) of the Internal Revenue Code), does not constitute coverage 
    within any category.
        (ii) Special rules. In counting an individual's creditable coverage 
    under the alternative method, the group health plan, or issuer, first 
    determines the amount of the individual's creditable coverage that may 
    be counted under paragraph (b) of this section, up to a total of 365 
    days of the most recent creditable coverage (546 days for a late 
    enrollee). The period over which this creditable coverage is determined 
    is referred to as the determination period. Then, for the category 
    specified under the alternative method, the plan or issuer counts 
    within the category all days of coverage that occurred during the 
    determination period (whether or not a significant break in coverage 
    for that category occurs), and reduces the individual's preexisting 
    condition exclusion period for that category by that number of days. 
    The plan or issuer may determine the amount of creditable coverage in 
    any other reasonable manner, uniformly applied, that is at least as 
    favorable to the individual.
        (iii) Example. The rules of this paragraph (c)(6) are illustrated 
    by the following example:
    
        Example. (i) Individual D enrolls in Employer V's plan on 
    January 1, 2001. Coverage under the plan includes prescription drug 
    benefits. On April 1, 2001, the plan ceases providing prescription 
    drug benefits. D's employment with Employer V ends on January 1, 
    2002, after D was covered under Employer V's group health plan for 
    365 days. D enrolls in Employer Y's plan on February 1, 2002 (D's 
    enrollment date). Employer Y's plan uses the alternative method of 
    counting creditable coverage and imposes a 12-month preexisting 
    condition exclusion on prescription drug benefits.
        (ii) In this Example, Employer Y's plan may impose a 275-day 
    preexisting condition exclusion with respect to D for prescription 
    drug benefits because D had 90 days of creditable coverage relating 
    to prescription drug benefits within D's determination period.
    
    
    Sec. 2590.701-5   Certification and disclosure of previous coverage.
    
        (a) Certificate of creditable coverage--(1) Entities required to 
    provide certificate--(i) In general. A group health plan, and each 
    health insurance issuer offering group health insurance coverage under 
    a group health plan, is required to furnish certificates of creditable 
    coverage in accordance with this paragraph (a) of this section.
        (ii) Duplicate certificates not required. An entity required to 
    provide a certificate under this paragraph (a)(1) for an individual is 
    deemed to have satisfied the certification requirements for that 
    individual if another party provides the certificate, but only to the 
    extent that information relating to the individual's creditable 
    coverage and waiting or affiliation period is provided by the other 
    party. For example, in the case of a group health plan funded through 
    an insurance policy, the issuer is deemed to have satisfied the 
    certification requirement with respect to a participant or beneficiary 
    if the plan actually provides a certificate that includes the 
    information required under paragraph (a)(3) of this section with 
    respect to the participant or beneficiary.
        (iii) Special rule for group health plans. To the extent coverage 
    under a plan consists of group health insurance coverage, the plan is 
    deemed to have satisfied the certification requirements under this 
    paragraph (a)(1) if any issuer offering the coverage is required to 
    provide the certificates pursuant to an agreement between the plan and 
    the issuer. For example, if there is an agreement between an issuer and 
    the plan sponsor under which the issuer agrees to provide certificates 
    for individuals covered under the plan, and the issuer fails to provide 
    a certificate to an individual when the plan would have been required 
    to provide one under this paragraph (a), then the issuer, but not the 
    plan, violates the certification requirements of this paragraph (a).
        (iv) Special rules for issuers--(A)(1) Responsibility of issuer for 
    coverage period. An issuer is not required to provide information 
    regarding coverage provided to an individual by another party.
        (2) Example. The rule of this paragraph (a)(1)(iv)(A) is 
    illustrated by the following example:
    
        Example. (i) A plan offers coverage with an HMO option from one 
    issuer and an indemnity option from a different issuer. The HMO has 
    not entered into an agreement with the plan to provide certificates 
    as permitted under paragraph (a)(1)(iii) of this section.
        (ii) In this Example, if an employee switches from the indemnity 
    option to the HMO option and later ceases to be covered under the 
    plan, any certificate provided by the HMO is not required to provide 
    information regarding the employee's coverage under the indemnity 
    option.
    
        (B)(1) Cessation of issuer coverage prior to cessation of coverage 
    under a plan. If an individual's coverage under an issuer's policy 
    ceases before the individual's coverage under the plan ceases, the 
    issuer is required to provide sufficient information to the plan (or to 
    another party designated by the plan) to enable a certificate to be 
    provided by the plan (or other party), after cessation of the 
    individual's coverage under the plan, that reflects the period of 
    coverage under the policy. The provision of that information to the 
    plan will satisfy the issuer's obligation to provide an automatic 
    certificate for that period of creditable coverage for the individual 
    under paragraph (a) (2)(ii) and (3) of this section. In addition, an 
    issuer providing that information is required to cooperate with the 
    plan in responding to any request made under paragraph (b)(2) of this 
    section (relating to the alternative method of counting creditable 
    coverage). If the individual's coverage under the plan ceases at the 
    time the individual's coverage under the issuer's policy ceases, the 
    issuer must provide an automatic certificate under paragraph (a)(2)(ii) 
    of this section. An issuer may presume that an individual whose 
    coverage ceases at a time other than the effective date for changing 
    enrollment
    
    [[Page 16947]]
    
    options has ceased to be covered under the plan.
        (2) Example. The rule of this paragraph (a)(1)(iv)(B) is 
    illustrated by the following example.
    
        Example. (i) A group health plan provides coverage under an HMO 
    option and an indemnity option with a different issuer, and only 
    allows employees to switch on each January 1. Neither the HMO nor 
    the indemnity issuer has entered into an agreement with the plan to 
    provide automatic certificates as permitted under paragraph 
    (a)(2)(ii) of this section.
        (ii) In this Example, if an employee switches from the indemnity 
    option to the HMO option on January 1, the issuer must provide the 
    plan (or a person designated by the plan) with appropriate 
    information with respect to the individual's coverage with the 
    indemnity issuer. However, if the individual's coverage with the 
    indemnity issuer ceases at a date other than January 1, the issuer 
    is instead required to provide the individual with an automatic 
    certificate.
    
        (2) Individuals for whom certificate must be provided; timing of 
    issuance--(i) Individuals. A certificate must be provided, without 
    charge, for participants or dependents who are or were covered under a 
    group health plan upon the occurrence of any of the events described in 
    paragraph (a)(2)(ii) or (iii) of this section.
        (ii) Issuance of automatic certificates. The certificates described 
    in this paragraph (a)(2)(ii) are referred to as automatic certificates.
        (A) Qualified beneficiaries upon a qualifying event. In the case of 
    an individual who is a qualified beneficiary (as defined in section 
    607(3) of the Act) entitled to elect COBRA continuation coverage, an 
    automatic certificate is required to be provided at the time the 
    individual would lose coverage under the plan in the absence of COBRA 
    continuation coverage or alternative coverage elected instead of COBRA 
    continuation coverage. A plan or issuer satisfies this requirement if 
    it provides the automatic certificate no later than the time a notice 
    is required to be furnished for a qualifying event under section 606 of 
    the Act (relating to notices required under COBRA).
        (B) Other individuals when coverage ceases. In the case of an 
    individual who is not a qualified beneficiary entitled to elect COBRA 
    continuation coverage, an automatic certificate is required to be 
    provided at the time the individual ceases to be covered under the 
    plan. A plan or issuer satisfies this requirement if it provides the 
    automatic certificate within a reasonable time period thereafter. In 
    the case of an individual who is entitled to elect to continue coverage 
    under a State program similar to COBRA and who receives the automatic 
    certificate not later than the time a notice is required to be 
    furnished under the State program, the certificate is deemed to be 
    provided within a reasonable time period after the cessation of 
    coverage under the plan.
        (C) Qualified beneficiaries when COBRA ceases. In the case of an 
    individual who is a qualified beneficiary and has elected COBRA 
    continuation coverage (or whose coverage has continued after the 
    individual became entitled to elect COBRA continuation coverage), an 
    automatic certificate is to be provided at the time the individual's 
    coverage under the plan ceases. A plan, or issuer, satisfies this 
    requirement if it provides the automatic certificate within a 
    reasonable time after coverage ceases (or after the expiration of any 
    grace period for nonpayment of premiums). An automatic certificate is 
    required to be provided to such an individual regardless of whether the 
    individual has previously received an automatic certificate under 
    paragraph (a)(2)(ii)(A) of this section.
        (iii) Any individual upon request. Requests for certificates are 
    permitted to be made by, or on behalf of, an individual within 24 
    months after coverage ceases. Thus, for example, a plan in which an 
    individual enrolls may, if authorized by the individual, request a 
    certificate of the individual's creditable coverage on behalf of the 
    individual from a plan in which the individual was formerly enrolled. 
    After the request is received, a plan or issuer is required to provide 
    the certificate by the earliest date that the plan or issuer, acting in 
    a reasonable and prompt fashion, can provide the certificate. A 
    certificate is required to be provided under this paragraph (a)(2)(iii) 
    even if the individual has previously received a certificate under this 
    paragraph (a)(2)(iii) or an automatic certificate under paragraph 
    (a)(2)(ii) of this section.
        (iv) Examples. The following examples illustrate the rules of this 
    paragraph (a)(2):
    
        Example 1. (i) Individual A terminates employment with Employer 
    Q. A is a qualified beneficiary entitled to elect COBRA continuation 
    coverage under Employer Q's group health plan. A notice of the 
    rights provided under COBRA is typically furnished to qualified 
    beneficiaries under the plan within 10 days after a covered employee 
    terminates employment.
        (ii) In this Example 1, the automatic certificate may be 
    provided at the same time that A is provided the COBRA notice.
        Example 2. (i) Same facts as Example 1, except that the 
    automatic certificate for A is not completed by the time the COBRA 
    notice is furnished to A.
        (ii) In this Example 2, the automatic certificate may be 
    provided within the period permitted by law for the delivery of 
    notices under COBRA.
        Example 3. (i) Employer R maintains an insured group health 
    plan. R has never had 20 employees and thus R's plan is not subject 
    to the COBRA continuation coverage provisions. However, R is in a 
    State that has a State program similar to COBRA. B terminates 
    employment with R and loses coverage under R's plan.
        (ii) In this Example 3, the automatic certificate may be 
    provided not later than the time a notice is required to be 
    furnished under the State program.
        Example 4. (i) Individual C terminates employment with Employer 
    S and receives both a notice of C's rights under COBRA and an 
    automatic certificate. C elects COBRA continuation coverage under 
    Employer S's group health plan. After four months of COBRA 
    continuation coverage and the expiration of a 30-day grace period, 
    S's group health plan determines that C's COBRA continuation 
    coverage has ceased due to failure to make a timely payment for 
    continuation coverage.
        (ii) In this Example 4, the plan must provide an updated 
    automatic certificate to C within a reasonable time after the end of 
    the grace period.
        Example 5. (i) Individual D is currently covered under the group 
    health plan of Employer T. D requests a certificate, as permitted 
    under paragraph (a)(2)(iii) of this section. Under the procedure for 
    Employer T's plan, certificates are mailed (by first class mail) 7 
    business days following receipt of the request. This date reflects 
    the earliest date that the plan, acting in a reasonable and prompt 
    fashion, can provide certificates.
        (ii) In this Example 5, the plan's procedure satisfies paragraph 
    (a)(2)(iii) of this section.
    
        (3) Form and content of certificate-- (i) Written certificate--(A) 
    In general. Except as provided in paragraph (a)(3)(i)(B) of this 
    section, the certificate must be provided in writing (including any 
    form approved by the Secretary as a writing).
        (B) Other permissible forms. No written certificate is required to 
    be provided under this paragraph (a) with respect to a particular event 
    described in paragraph (a)(2) (ii) or (iii) of this section, if--
        (1) An individual is entitled to receive a certificate;
        (2) The individual requests that the certificate be sent to another 
    plan or issuer instead of to the individual;
        (3) The plan or issuer that would otherwise receive the certificate 
    agrees to accept the information in this paragraph (a)(3) through means 
    other than a written certificate (e.g., by telephone); and
        (4) The receiving plan or issuer receives such information from the 
    sending plan or issuer in such form within the time periods required 
    under paragraph (a)(2) of this section.
    
    [[Page 16948]]
    
        (ii) Required information. The certificate must include the 
    following--
        (A) The date the certificate is issued;
        (B) The name of the group health plan that provided the coverage 
    described in the certificate;
        (C) The name of the participant or dependent with respect to whom 
    the certificate applies, and any other information necessary for the 
    plan providing the coverage specified in the certificate to identify 
    the individual, such as the individual's identification number under 
    the plan and the name of the participant if the certificate is for (or 
    includes) a dependent;
        (D) The name, address, and telephone number of the plan 
    administrator or issuer required to provide the certificate;
        (E) The telephone number to call for further information regarding 
    the certificate (if different from paragraph (a)(3)(ii)(D) of this 
    section);
        (F) Either--
        (1) A statement that an individual has at least 18 months (for this 
    purpose, 546 days is deemed to be 18 months) of creditable coverage, 
    disregarding days of creditable coverage before a significant break in 
    coverage, or
        (2) The date any waiting period (and affiliation period, if 
    applicable) began and the date creditable coverage began; and
        (G) The date creditable coverage ended, unless the certificate 
    indicates that creditable coverage is continuing as of the date of the 
    certificate.
        (iii) Periods of coverage under certificate. If an automatic 
    certificate is provided pursuant to paragraph (a)(2)(ii) of this 
    section, the period that must be included on the certificate is the 
    last period of continuous coverage ending on the date coverage ceased. 
    If an individual requests a certificate pursuant to paragraph 
    (a)(2)(iii) of this section, a certificate must be provided for each 
    period of continuous coverage ending within the 24-month period ending 
    on the date of the request (or continuing on the date of the request). 
    A separate certificate may be provided for each such period of 
    continuous coverage.
        (iv) Combining information for families. A certificate may provide 
    information with respect to both a participant and the participant's 
    dependents if the information is identical for each individual or, if 
    the information is not identical, certificates may be provided on one 
    form if the form provides all the required information for each 
    individual and separately states the information that is not identical.
        (v) Model certificate. The requirements of paragraph (a)(3)(ii) of 
    this section are satisfied if the plan or issuer provides a certificate 
    in accordance with a model certificate authorized by the Secretary.
        (vi) Excepted benefits; categories of benefits. No certificate is 
    required to be furnished with respect to excepted benefits described in 
    Sec. 2590.732. In addition, the information in the certificate 
    regarding coverage is not required to specify categories of benefits 
    described in Sec. 2590.701-4(c) (relating to the alternative method of 
    counting creditable coverage). However, if excepted benefits are 
    provided concurrently with other creditable coverage (so that the 
    coverage does not consist solely of excepted benefits), information 
    concerning the benefits may be required to be disclosed under paragraph 
    (b) of this section.
        (4) Procedures--(i) Method of delivery. The certificate is required 
    to be provided to each individual described in paragraph (a)(2) of this 
    section or an entity requesting the certificate on behalf of the 
    individual. The certificate may be provided by first-class mail. If the 
    certificate or certificates are provided to the participant and the 
    participant's spouse at the participant's last known address, then the 
    requirements of this paragraph (a)(4) are satisfied with respect to all 
    individuals residing at that address. If a dependent's last known 
    address is different than the participant's last known address, a 
    separate certificate is required to be provided to the dependent at the 
    dependent's last known address. If separate certificates are being 
    provided by mail to individuals who reside at the same address, 
    separate mailings of each certificate are not required.
        (ii) Procedure for requesting certificates. A plan or issuer must 
    establish a procedure for individuals to request and receive 
    certificates pursuant to paragraph (a)(2)(iii) of this section.
        (iii) Designated recipients. If an automatic certificate is 
    required to be provided under paragraph (a)(2)(ii) of this section, and 
    the individual entitled to receive the certificate designates another 
    individual or entity to receive the certificate, the plan or issuer 
    responsible for providing the certificate is permitted to provide the 
    certificate to the designated party. If a certificate is required to be 
    provided upon request under paragraph (a)(2)(iii) of this section and 
    the individual entitled to receive the certificate designates another 
    individual or entity to receive the certificate, the plan or issuer 
    responsible for providing the certificate is required to provide the 
    certificate to the designated party.
        (5) Special rules concerning dependent coverage--(i)(A) Reasonable 
    efforts. A plan or issuer is required to use reasonable efforts to 
    determine any information needed for a certificate relating to the 
    dependent coverage. In any case in which an automatic certificate is 
    required to be furnished with respect to a dependent under paragraph 
    (a)(2)(ii) of this section, no individual certificate is required to be 
    furnished until the plan or issuer knows (or making reasonable efforts 
    should know) of the dependent's cessation of coverage under the plan.
        (B) Example. The rules of this paragraph (a)(5) are illustrated by 
    the following example:
    
        Example. (i) A group health plan covers employees and their 
    dependents. The plan annually requests all employees to provide 
    updated information regarding dependents, including the specific 
    date on which an employee has a new dependent or on which a person 
    ceases to be a dependent of the employee.
        (ii) In this Example, the plan has satisfied the standard in 
    this paragraph (a)(5)(i) of this section that it make reasonable 
    efforts to determine the cessation of dependents' coverage and the 
    related dependent coverage information.
    
        (ii) Special rules for demonstrating coverage. If a certificate 
    furnished by a plan or issuer does not provide the name of any 
    dependent of an individual covered by the certificate, the individual 
    may, if necessary, use the procedures described in paragraph (c)(4) of 
    this section for demonstrating dependent status. In addition, an 
    individual may, if necessary, use these procedures to demonstrate that 
    a child was enrolled within 30 days of birth, adoption, or placement 
    for adoption. See Sec. 2590.701-3(b), under which such a child would 
    not be subject to a preexisting condition exclusion.
        (iii) Transaction rule for dependent coverage through June 30, 
    1998--(A) In general. A group health plan or health insurance issuer 
    that cannot provide the names of dependents (or related coverage 
    information) for purposes of providing a certificate of coverage for a 
    dependent may satisfy the requirements of paragraph (a)(3)(ii)(C) of 
    this section by providing the name of the participant covered by the 
    group health plan or health insurance issuer and specifying that the 
    type of coverage described in the certificate is for dependent coverage 
    (e.g., family coverage or employee-plus-spouse coverage).
        (B) Certificates provided on request. For purposes of certificates 
    provided on the request of, or on behalf of, an individual pursuant to 
    paragraph (a)(2)(iii) of this section, a plan or issuer
    
    [[Page 16949]]
    
    must make reasonable efforts to obtain and provide the names of any 
    dependent covered by the certificate where such information is 
    requested to be provided. If a certificate does not include the name of 
    any dependent of an individual covered by the certificate, the 
    individual may, if necessary, use the procedures described in paragraph 
    (c) of this section for submitting documentation to establish that the 
    creditable coverage in the certificate applies to the dependent.
        (C) Demonstrating a dependent's creditable coverage. See paragraph 
    (c)(4) of this section for special rules to demonstrate dependent 
    status.
        (D) Duration. This paragraph (a)(5)(iii) is only effective for 
    certificates provided with respect to events occurring through June 30, 
    1998.
        (6) Special certification rules for entities not subject to Part 7 
    of Subtitle B of Title I of the Act--(i) Issuers. For special rules 
    requiring that issuers, not subject to part 7 of subtitle B of title I 
    of the Act, provide certificates consistent with the rules in this 
    section, including issuers offering coverage with respect to creditable 
    coverage described in sections 701(c)(1)(G) through (c)(1)(J) of the 
    Act (coverage under a State health benefits risk pool, the Federal 
    Employees Health Benefits Program, a public health plan, and a health 
    benefit plan under section 5(e) of the Peace Corps Act), see section 
    2721(b)(1)(B) of the PHSA (requiring certificates by issuers offering 
    health insurance covering in connection with a group health plan, 
    including a church plan or a governmental plan (including the Federal 
    Employees Health Benefits Program (FEHBP)). In addition, see section 
    2743 of the PHSA applicable to health insurance issuers in the 
    individual market. (However, this section does not require a 
    certificate to be provided with respect to short-term limited duration 
    insurance, as described in the definition of individual health 
    insurance coverage in Sec. 2590.701-2, that is not provided by a group 
    health plan or issuer offering health insurance in connection with a 
    group health plan.)
        (ii) Other entities. For special rules requiring that certain other 
    entities, not subject to part 7 of subtitle B of title I of the Act, 
    provide certificates consistent with the rules in this section, see 
    section 2791(a)(3) of the PHSA applicable to entities described in 
    sections 2701(c)(1)(C), (D), (E), and (F) of PHSA (relating to 
    Medicare, Medicaid, CHAMPUS, and Indian Health Service), section 
    2721(b)(1)(A) of the PHSA applicable to nonfederal governmental plans 
    generally, section 2721(b)(2)(C)(ii) of the PHSA applicable to 
    nonfederal governmental plans that elect to be excluded from the 
    requirements of subparts 1 and 3 of part A of Title XXVII of the PHSA, 
    and section 9805(a) of the Internal Revenue Code applicable to group 
    health plans, which includes church plans (as defined in section 414(e) 
    of the Internal Revenue Code).
        (b) Disclosure of coverage to a plan, or issuer, using the 
    alternative method of counting creditable coverage--(1) In general. If 
    an individual enrolls in a group health plan with respect to which the 
    plan, or issuer, uses the alternative method of counting creditable 
    coverage described in Sec. 2590.701-4(c) the individual provides a 
    certificate of coverage under paragraph (a) of this section, and the 
    plan or issuer in which the individual enrolls so requests, the entity 
    that issued the certificate (the prior entity) is required to disclose 
    promptly to a requesting plan or issuer (the requesting entity) the 
    information set forth in paragraph (b)(2) of this section.
        (2) Information to be disclosed. Information to be disclosed. The 
    prior entity is required to identify to the requesting entity the 
    categories of benefits with respect to which the requesting entity is 
    using the alternative method of counting creditable coverage, and the 
    requesting entity may identify specific information that the requesting 
    entity reasonably needs in order to determine the individual's 
    creditable coverage with respect to any such category. The prior entity 
    is required to disclose promptly to the requesting entity the 
    creditable coverage information so requested.
        (3) Charge for providing information. The prior entity furnishing 
    the information under paragraph (b) of this section may charge the 
    requesting entity for the reasonable cost of disclosing such 
    information.
        (c) Ability of an individual to demonstrate creditable coverage and 
    waiting period information--(1) In general. The rules in this paragraph 
    (c) implement section 701(c)(4) of the Act, which permits individuals 
    to establish creditable coverage through means other than certificates, 
    and section 701(e)(3) of the Act, which requires the Secretary to 
    establish rules designed to prevent an individual's subsequent coverage 
    under a group health plan or health insurance coverage from being 
    adversely affected by an entity's failure to provide a certificate with 
    respect to that individual. If the accuracy of a certificate is 
    contested or a certificate is unavailable when needed by the 
    individual, the individual has the right to demonstrate creditable 
    coverage (and waiting or affiliation periods) through the presentation 
    of documents or other means. For example, the individual may make such 
    a demonstration when--
        (i) An entity has failed to provide a certificate within the 
    required time period;
        (ii) The individual has creditable coverage but an entity may not 
    be required to provide a certificate of the coverage pursuant to 
    paragraph (a) of this section;
        (iii) The coverage is for a period before July 1, 1996;
        (iv) The individual has an urgent medical condition that 
    necessitates a determination before the individual can deliver a 
    certificate to the plan; or
        (v) The individual lost a certificate that the individual had 
    previously received and is unable to obtain another certificate.
        (2) Evidence of creditable coverage--(i) Consideration of evidence. 
    A plan or issuer is required to take into account all information that 
    it obtains or that is presented on behalf of an individual to make a 
    determination, based on the relevant facts and circumstances, whether 
    an individual has creditable coverage and is entitled to offset all or 
    a portion of any preexisting condition exclusion period. A plan or 
    issuer shall treat the individual as having furnished a certificate 
    under paragraph (a) of this section if the individual attests to the 
    period of creditable coverage, the individual also presents relevant 
    corroborating evidence of some creditable coverage during the period, 
    and the individual cooperates with the plan's or issuer's efforts to 
    verify the individual's coverage. For this purpose, cooperation 
    includes providing (upon the plan's or issuer's request) a written 
    authorization for the plan or issuer to request a certificate on behalf 
    of the individual, and cooperating in efforts to determine the validity 
    of the corroborating evidence and the dates of creditable coverage. 
    While a plan or issuer may refuse to credit coverage where the 
    individual fails to cooperate with the plan's or issuer's efforts to 
    verify coverage, the plan or issuer may not consider an individual's 
    inability to obtain a certificate to be evidence of the absence of 
    creditable coverage.
        (ii) Documents. Documents that may establish creditable coverage 
    (and waiting periods or affiliation periods) in the absence of a 
    certificate include explanations of benefit claims (EOB) or other 
    correspondence from a plan or issuer indicating coverage, pay stubs 
    showing a payroll deduction for health coverage, a health insurance 
    identification card, a certificate of coverage under a group health 
    policy,
    
    [[Page 16950]]
    
    records from medical care providers indicating health coverage, third 
    party statements verifying periods of coverage, and any other relevant 
    documents that evidence periods of health coverage.
        (iii) Other evidence. Creditable coverage (and waiting period or 
    affiliation period information) may also be established through means 
    other than documentation, such as by a telephone call from the plan or 
    provider to a third party verifying creditable coverage.
        (iv) Example. The rules of this paragraph (c)(2) are illustrated by 
    the following example:
    
        Example. (i) Individual F terminates employment with Employer W 
    and, a month later, is hired by Employer X. Employer X's group 
    health plan imposes a preexisting condition exclusion of 12 months 
    on new enrollees under the plan and uses the standard method of 
    determining creditable coverage. F fails to receive a certificate of 
    prior coverage from the self-insured group health plan maintained by 
    F's prior employer, Employer W, and requests a certificate. However, 
    F (and Employer X's plan, on F's behalf) is unable to obtain a 
    certificate from Employer W's plan. F attests that, to the best of 
    F's knowledge, F had at least 12 months of continuous coverage under 
    Employer W's plan, and that the coverage ended no earlier than F's 
    termination of employment from Employer W. In addition, F presents 
    evidence of coverage, such as an explanation of benefits for a claim 
    that was made during the relevant period.
        (ii) In this Example, based solely on these facts, F has 
    demonstrated creditable coverage for the 12 months of coverage under 
    Employer W's plan in the same manner as if F had presented a written 
    certificate of creditable coverage.
    
        (3) Demonstrating categories of creditable coverage. Procedures 
    similar to those described in this paragraph (c) apply in order to 
    determine an individual's creditable coverage with respect to any 
    category under paragraph (b) of this section (relating to determining 
    creditable coverage under the alternative method).
        (4) Demonstrating dependent status. If, in the course of providing 
    evidence (including a certificate) of creditable coverage, an 
    individual is required to demonstrate dependent status, the group 
    health plan or issuer is required to treat the individual as having 
    furnished a certificate showing the dependent status if the individual 
    attests to such dependency and the period of such status and the 
    individual cooperates with the plan's or issuer's efforts to verify the 
    dependent status.
        (d) Determination and notification of creditable coverage--(1) 
    Resonable time period. In the event that a group health plan or health 
    insurance issuer offering group health insurance coverage receives 
    information under paragraph (a) of this section (certifications), 
    paragraph (b) of this section (disclosure of information relating to 
    the alternative method), or paragraph (c) of this section (other 
    evidence of creditable coverage), the entity is required, within a 
    reasonable time period following receipt of the information, to make a 
    determination regarding the individual's period of creditable coverage 
    and notify the individual of the determination in accordance with 
    paragraph (d)(2) of this section. Whether a determination and 
    notification regarding an individual's creditable coverage is made 
    within a reasonable time period is determined based on the relevant 
    facts and circumstances. Relevant facts and circumstances include 
    whether a plan's application of a preexisting condition exclusion would 
    prevent an individual from having access to urgent medical services.
        (2) Notification to individual of period of preexisting condition 
    exclusion. A plan or issuer seeking to impose a preexisting condition 
    exclusion is required to disclose to the individual, in writing, its 
    determination of any preexisting condition exclusion period that 
    applies to the individual, and the basis for such determination, 
    including the source and substance of any information on which the plan 
    or issuer relied. In addition, the plan or issuer is required to 
    provide the individual with a written explanation of any appeal 
    procedures established by the plan or issuer, and with a reasonable 
    opportunity to submit additional evidence of creditable coverage. 
    However, nothing in this paragraph (d) or paragraph (c) of this section 
    prevents a plan or issuer from modifying an initial determination of 
    creditable coverage if it determines that the individual did not have 
    the claimed creditable coverage, provided that--
        (i) A notice of such reconsideration, as described in this 
    paragraph (d), is provided to the individual; and
        (ii) Until the final determination is made, the plan or issuer, for 
    purposes of approving access to medical services (such as a pre-surgery 
    authorization), acts in a manner consistent with the initial 
    determination.
        (3) Examples. The following examples illustrate this paragraph (d):
    
        Example 1. (i) Individual G is hired by Employer Y. Employer Y's 
    group health plan imposes a preexisting condition exclusion for 12 
    months with respect to new enrollees and uses the standard method of 
    determining creditable coverage. Employer Y's plan determines that G 
    is subject to a 4-month preexisting condition exclusion, based on a 
    certificate of creditable coverage that is provided by G to Employer 
    Y's plan indicating 8 months of coverage under G's prior group 
    health plan.
        (ii) In this Example 1, Employer Y's plan must notify G within a 
    reasonable period of time following receipt of the certificate that 
    G is subject to a 4-month preexisting condition exclusion beginning 
    on G's enrollment date in Y's plan.
        Example 2. (i) Same facts as in Example 1, except that Employer 
    Y's plan determines that G has 14 months of creditable coverage 
    based on G's certificate indicating 14 months of creditable coverage 
    under G's prior plan.
        (ii) In this Example 2, Employer Y's plan is not required to 
    notify G that G will not be subject to a preexisting condition 
    exclusion.
        Example 3. (i) Individual H is hired by Employer Z. Employer Z's 
    group health plan imposes a preexisting condition exclusion for 12 
    months with respect to new enrollees and uses the standard method of 
    determining creditable coverage. H develops an urgent health 
    condition before receiving a certificate of prior coverage. H 
    attests to the period of prior coverage, presents corroborating 
    documentation of the coverage period, and authorizes the plan to 
    request a certificate on H's behalf.
        (ii) In this Example 3, Employer Z's plan must review the 
    evidence presented by H. In addition, the plan must make a 
    determination and notify H regarding any preexisting condition 
    exclusion period that applies to H (and the basis of such 
    determination) within a reasonable time period following receipt of 
    the evidence that is consistent with the urgency of H's health 
    condition (this determination may be modified as permitted under 
    paragraph (d)(2) of this section).
    
    
    Sec. 2590.701-6  Special enrollment periods.
    
        (a) Special enrollment for certain individuals who lose coverage--
    (1) In general. A group health plan, and a health insurance issuer 
    offering group health insurance coverage in connection with a group 
    health plan, is required to permit employees and dependents described 
    in paragraph (a) (2), (3), or (4) of this section to enroll for 
    coverage under the terms of the plan if the conditions in paragraph 
    (a)(5) of this section are satisfied and the enrollment is requested 
    within the period described in paragraph (a)(6) of this section. The 
    enrollment is effective at the time described in paragraph (a)(7) of 
    this section. The special enrollment rights under this paragraph (a) 
    apply without regard to the dates on which an individual would 
    otherwise be able to enroll under the plan.
        (2) Special enrollment of an employee only. An employee is 
    described in this paragraph (a)(2) if the employee is eligible, but not 
    enrolled, for coverage under the terms of the plan and, when enrollment 
    was previously offered to the employee under the plan and was declined 
    by the employee, the employee
    
    [[Page 16951]]
    
    was covered under another group health plan or had other health 
    insurance coverage.
        (3) Special enrollment of dependents only. A dependent is described 
    in this paragraph (a)(3) if the dependent is a dependent of an employee 
    participating in the plan, the dependent is eligible, but not enrolled, 
    for coverage under the terms of the plan, and, when enrollment was 
    previously offered under the plan and was declined, the dependent was 
    covered under another group health plan or had other health insurance 
    coverage.
        (4) Special enrollment of both employee and dependent. An employee 
    and any dependent of the employee are described in this paragraph 
    (a)(4) if they are eligible, but not enrolled, for coverage under the 
    terms of the plan and, when enrollment was previously offered to the 
    employee or dependent under the plan and was declined, the employee or 
    dependent was covered under another group health plan or had other 
    health insurance coverage.
        (5) Conditions for special enrollment. An employee or dependent is 
    eligible to enroll during a special enrollment period if each of the 
    following applicable conditions is met:
        (i) When the employee declined enrollment for the employee or the 
    dependent, the employee stated in writing that coverage under another 
    group health plan or other health insurance coverage was the reason for 
    declining enrollment. This paragraph (a)(5)(i) applies only if--
        (A) The plan required such a statement when the employee declined 
    enrollment; and
        (B) The employee is provided with notice of the requirement to 
    provide the statement in this paragraph (a)(5)(i) (and the consequences 
    of the employee's failure to provide the statement) at the time the 
    employee declined enrollment.
        (ii)(A) When the employee declined enrollment for the employee or 
    dependent under the plan, the employee or dependent had COBRA 
    continuation coverage under another plan and COBRA continuation 
    coverage under that other plan has since been exhausted; or
        (B) If the other coverage that applied to the employee or dependent 
    when enrollment was declined was not under a COBRA continuation 
    provision, either the other coverage has been terminated as a result of 
    loss of eligibility for the coverage or employer contributions towards 
    the other coverage has been terminated. For this purpose, loss of 
    eligibility for coverage includes a loss of coverage as a result of 
    legal separation, divorce, death, termination of employment, reduction 
    in the number of hours of employment, and any loss of eligibility after 
    a period that is measured by reference to any of the foregoing. Thus, 
    for example, if an employee's coverage ceases following a termination 
    of employment and the employee is eligible for but fails to elect COBRA 
    continuation coverage, this is treated as a loss of eligibility under 
    this paragraph (a)(5)(ii)(B). However, loss of eligibility does not 
    include a loss due to failure of the individual or the participant to 
    pay premiums on a timely basis or termination of coverage for cause 
    (such as making a fraudulent claim or an intentional misrepresentation 
    of a material fact in connection with the plan). In addition, for 
    purposes of this paragraph (a)(5)(ii)(B), employer contributions 
    include contributions by any current or former employer (of the 
    individual or another person) that was contributing to coverage for the 
    individual.
        (6) Length of special enrollment period. The employee is required 
    to request enrollment (for the employee or the employee's dependent, as 
    described in paragraph (a) (2), (3), or (4) of this section) not later 
    than 30 days after the exhaustion of the other coverage described in 
    paragraph (a)(5)(ii)(A) of this section or termination of the other 
    coverage as a result of the loss of eligibility for the other coverage 
    for items described in paragraph (a)(5)(ii)(B) of this section or 
    following the termination of employer contributions toward that other 
    coverage. The plan may impose the same requirements that apply to 
    employees who are otherwise eligible under the plan to immediately 
    request enrollment for coverage (e.g., that the request be made in 
    writing).
        (7) Effective date of enrollment. Enrollment is effective not later 
    than the first day of the first calendar month beginning after the date 
    the completed request for enrollment is received.
        (b) Special enrollment with respect to certain dependent 
    beneficiaries--(1) In general. A group health plan that makes coverage 
    available with respect to dependents of a participant is required to 
    provide a special enrollment period to permit individuals described in 
    paragraph (b) (2), (3), (4), (5), or (6) of this section to be enrolled 
    for coverage under the terms of the plan if the enrollment is requested 
    within the time period described in paragraph (b)(7) of this section. 
    The enrollment is effective at the time described in paragraph (b)(8) 
    of this section. The special enrollment rights under this paragraph (b) 
    apply without regard to the dates on which an individual would 
    otherwise be able to enroll under the plan.
        (2) Special enrollment of an employee who is eligible but not 
    enrolled. An individual is described in this paragraph (b)(2) if the 
    individual is an employee who is eligible, but not enrolled, in the 
    plan, the individual would be a participant but for a prior election by 
    the individual not to enroll in the plan during a previous enrollment 
    period, and a person becomes a dependent of the individual through 
    marriage, birth, or adoption or placement for adoption.
        (3) Specil enrollment of a spouse of a participant. An individual 
    is described in this paragraph (b)(3) if either--
        (i) The individual becomes the spouse of a participant; or
        (ii) The individual is a spouse of the participant and a child 
    becomes a dependent of the participant through birth, adoption or 
    placement for adoption.
        (4) Special enrollment of an employee who is eligible but not 
    enrolled and the spouse of such employee. An employee who is eligible, 
    but not enrolled, in the plan, and an individual who is a dependent of 
    such employee, are described in this paragraph (b)(4) if the employee 
    would be a participant but for a prior election by the employee not to 
    enroll in the plan during a previous enrollment period, and either--
        (i) The employee and the individual become married; or
        (ii) The employee and individual are married and a child becomes a 
    dependent of the employee through birth, adoption or placement for 
    adoption.
        (5) Special enrollment of a dependent of a participant. An 
    individual is described in this paragraph (b)(5) if the individual is a 
    dependent of a participant and the individual becomes a dependent of 
    such participant through marriage, birth, or adoption or placement for 
    adoption.
        (6) Sepcial enrollment of an employee who is eligible but not 
    enrolled and a new dependent. An employee who is eligible, but not 
    enrolled, in the plan, and an individual who is a dependent of the 
    employee, are described in this paragraph (b)(6) if the employee would 
    be a participant but for a prior election by the employee not to enroll 
    in the plan during a previous enrollment period, and the dependent 
    becomes a dependent of the employee through marriage, birth, or 
    adoption or placement for adoption.
        (7) Length of special enrollment period. The special enrollment 
    period under paragraph (b)(1) of this section is a period of not less 
    than 30 days and begins on the date of the marriage, birth, or adoption 
    or placement for adoption
    
    [[Page 16952]]
    
    (except that such period does not begin earlier than the date the plan 
    makes dependent coverage generally available).
        (8) Effective date of enrollment. Enrollment is effective--
        (i) In the case of marriage, not later than the first day of the 
    first calendar month beginning after the date the completed request for 
    enrollment is received by the plan;
        (ii) In the case of a dependent's birth, the date of such birth; 
    and
        (iii) In the case of a dependent's adoption or placement for 
    adoption, the date of such adoption or placement for adoption.
        (9) Example. The rules of this paragraph (b) are illustrated by the 
    following example:
    
        Example. (i) Employee A is hired on September 3, 1998 by 
    Employer X, which has a group health plan in which A can elect to 
    enroll either for employee-only coverage, for employee-plus-spouse 
    coverage, or for family coverage, effective on the first day of any 
    calendar quarter thereafter. A is married and has no children. A 
    does not elect to join Employer X's plan (for employee-only 
    coverage, employee-plus-spouse coverage, or family coverage) on 
    October 1, 1998 or January 1, 1999. On February 15, 1999, a child is 
    placed for adoption with A and A's spouse.
        (ii) In this Example, the conditions for special enrollment of 
    an employee with a new dependent under paragraph (b)(2) of this 
    section are satisfied, the conditions for special enrollment of an 
    employee and a spouse with a new dependent under paragraph (b)(4) of 
    this section are satisfied, and the conditions for special 
    enrollment of an employee and a new dependent under paragraph (b)(6) 
    of this section are satisfied. Accordingly, Employer X's plan will 
    satisfy this paragraph (b) if and only if it allows A to elect, by 
    filing the required forms by March 16, 1999, to enroll in Employer 
    X's plan either with employee-only coverage, with employee-plus-
    spouse coverage, or with family coverage, effective as of February 
    15, 1999.
    
        (c) Notice of enrollment rights. On or before the time an employee 
    is offered the opportunity to enroll in a group health plan, the plan 
    is required to provide the employee with a description of the plan's 
    special enrollment rules under this section. For this purpose, the plan 
    may use the following model description of the special enrollment rules 
    under this section:
    
        If you are declining enrollment for yourself or your dependents 
    (including your spouse) because of other health insurance coverage, 
    you may in the future be able to enroll yourself or your dependents 
    in this plan, provided that you request enrollment within 30 days 
    after your other coverage ends. In addition, if you have a new 
    dependent as a result of marriage, birth, adoption, or placement for 
    adoption, you may be able to enroll yourself and your dependents, 
    provided that you request enrollment within 30 days after the 
    marriage, birth, adoption, or placement for adoption.
    
        (d)(1) Special enrollment date definition. A special enrollment 
    date for an individual means any date in paragraph (a)(7) or (b)(8) of 
    this section on which the individual has a right to have enrollment in 
    a group health plan become effective under this section.
        (2) Examples. The rules of this section are illustrated by the 
    following examples:
    
        Example 1. (i)(A) Employer Y maintains a group health plan that 
    allows employees to enroll in the plan either--
        (1) Effective on the first day of employment by an election 
    filed within three days thereafter;
        (2) Effective on any subsequent January 1 by an election made 
    during the preceding months of November or December; or
        (3) Effective as of any special enrollment date described in 
    this section.
        (B) Employee B is hired by Employer Y on March 15, 1998 and does 
    not elect to enroll in Employer Y's plan until January 31, 1999 when 
    B loses coverage under another plan. B elects to enroll in Employer 
    Y's plan effective on February 1, 1999, by filing the completed 
    request form by January 31, 1999, in accordance with the special 
    rule set forth in paragraph (a) of this section.
        (ii) In this Example 1, B has enrolled on a special enrollment 
    date because the enrollment is effective at a date described in 
    paragraph (a)(7) of this section.
        Example 2. (i) Same facts as Example 1, except that B's loss of 
    coverage under the other plan occurs on December 31, 1998 and B 
    elect to enroll in Employer Y's plan effective on January 1, 1999 by 
    filing the completed request form by December 31, 1998, in 
    accordance with the special rule set forth in paragraph (a) of this 
    section.
        (ii) In this Example 2, B has enrolled on a special enrollment 
    date because the enrollment is effective at a date described in 
    paragraph (a)(7) of this section (even though this date is also a 
    regular enrollment date under the plan).
    
    
    Sec. 2590.701-7  HMO affiliation period as alternative to preexisting 
    condition exclusion.
    
        (a) In general. A group health plan offering health insurance 
    coverage through an HMO, or an HMO that offers health insurance 
    coverage in connection with a group health plan, may impose an 
    affiliation period only if each of the requirements in paragraph (b) of 
    this section is satisfied.
        (b) Requirements for affiliation period. (1) No preexisting 
    condition exclusion is imposed with respect to any coverage offered by 
    the HMO in connection with the particular group health plan.
        (2) No premium is charged to a participant or beneficiary for the 
    affiliation period.
        (3) The affiliation period for the HMO coverage is applied 
    uniformly without regard to any health status-related factors.
        (4) The affiliation period does not exceed 2 months (or 3 months in 
    the case of a late enrollee).
        (5) The affiliation period begins on the enrollment date.
        (6) The affiliation period for enrollment in the HMO under a plan 
    runs concurrently with any waiting period.
        (c) Alternatives to affiliation period. An HMO may use alternative 
    methods in lieu of an affiliation period to address adverse selection, 
    as approved by the State insurance commissioner or other official 
    designated to regulate HMOs. Nothing in the part requires a State to 
    receive proposals for or approve alternatives to affiliation periods.
    
    
    Sec. 2590.702   Prohibiting discrimination against participants and 
    beneficiaries based on a health status-related factor.
    
        (a) In eligibility to enroll--(1) In general. Subject to paragraph 
    (a)(2) of this section, a group health plan, and a health insurance 
    issuer offering group health insurance coverage in connection with a 
    group health plan, may not establish rules for eligibility (including 
    continued eligibility) of any individual to enroll under the terms of 
    the plan based on any of the following health status-related factors in 
    relation to the individual or a dependent of the individual.
        (i) Health status.
        (ii) Medical condition (including both physical and mental 
    illnesses), as defined in Sec. 2590.701-2.
        (iii) Claims experience.
        (iv) Receipt of health care.
        (v) Medical history.
        (vi) Genetic information, as defined in Sec. 2590.701-2.
        (vii) Evidence of insurability (including conditions arising out of 
    acts of domestic violence).
        (viii) Disability.
        (2) No application to benefits or exclusions. To the extent 
    consistent with section 701 of the Act and Sec. 2590.701-3, paragraph 
    (a)(1) of this section shall not be construed--
        (i) To require a group health plan, or a health insurance issuer 
    offering group health insurance coverage, to provide particular 
    benefits other than those provided under the terms of such plan or 
    coverage; or
        (ii) To prevent such a plan or issuer from establishing limitation 
    or restrictions on the amount, level, extent, or nature of the benefits 
    or coverage for similarly situated individuals enrolled in the plan or 
    coverage.
    
    [[Page 16953]]
    
        (3) Construction. For purposes of paragraph (a)(1) of this section, 
    rules for eligibility to enroll include rule defining any applicable 
    waiting (or affiliation) periods for such enrollment and rules relating 
    to late and special enrollment.
        (4) Example. The following example illustrates the rules of this 
    paragraph (a):
    
        Example. (i) An employer sponsors a group health plan that is 
    available to all employees who enroll within the first 30 days of 
    their employment. However, individuals who do not enroll in the 
    first 30 days cannot enroll later unless they pass a physical 
    examination.
        (ii) In this Example, the plan discriminates on the basis of one 
    or more health status-related factors.
    
        (b) In premiums or contributions--(1) In general. A group health 
    plan, and a health insurance issuer offering health insurance coverage 
    in connection with a group health plan, may not require an individual 
    (as a condition of enrollment or continued enrollment under the plan) 
    to pay a premium or contribution that is greater than the premium or 
    contribution for a similarly situated individual enrolled in the plan 
    based on any health status-related factor, in relation to the 
    individual or a dependent of the individual.
        (2) Construction. Nothing in paragraph (b)(1) of this section shall 
    be construed--
        (i) To restrict the amount that an employer may be charged by an 
    issuer for coverage under a group health plan; or
        (ii) To prevent a group health plan, and a health insurance issuer 
    offering group health insurance coverage, from establishing premium 
    discounts or rebates or modifying otherwise applicable copayments or 
    deductibles in return for adherence to a bona fide wellness program. 
    For purposes of this section, a bona fide wellness program is a program 
    of health promotion and disease prevention.
        (3) Example. The rules of this paragraph (b) are illustrated by the 
    following example:
    
        Example. (i) Plan X offers a premium discount to participants 
    who adhere to a cholesterol-reduction wellness program. Enrollees 
    are expected to keep a diary of their food intake over 6 weeks. They 
    periodically submit the diary to the plan physician who responds 
    with suggested diet modifications. Enrollees are to modify their 
    diets in accordance with the physician's recommendations. At the end 
    of the 6 weeks, enrollees are given a cholesterol test and those who 
    achieve a count under 200 receive a premium discount.
        (ii) In this Example, because enrollees who otherwise comply 
    with the program may be unable to achieve a cholesterol count under 
    200 due to a health status-related factor, this is not a bona fide 
    wellness program and such discounts would discriminate impermissibly 
    based on one or more health status-related factors. However, if, 
    instead, individuals covered by the plan were entitled to receive 
    the discount for complying with the diary and dietary requirements 
    and were not required to pass a cholesterol test, the program would 
    be a bona fide wellness program.
    
    
    Sec. 2590.703   Guaranteed renewability in multiemployer plans and 
    multiple employer welfare arrangements. [Reserved]
    
    Subpart B--Other Requirements
    
    
    Sec. 2590.711  Standard relating to benefits for mothers and newborns. 
    [Reserved]
    
    
    Sec. 2590.712  Parity in the application of certain limits to mental 
    health benefits. [Reserved]
    
    Subpart C--General Provisions
    
    
    Sec. 2590.731  Preemption; State flexibility; construction.
    
        (a) Continued applicability of State law with respect to health 
    insurance issuers. Subject to paragraph (b) of this section and except 
    as provided in paragraph (c) of this section, part 7 of subtitle B of 
    title I of the Act is not to be construed to supersede any provision of 
    State law which establishes, implements, or continues in effect any 
    standard or requirement solely relating to health insurance issuers in 
    connection with group health insurance coverage except to the extent 
    that such standard or requirement prevents the application of a 
    requirements of this part.
        (b) Continued preemption with respect to group health plans. 
    Nothing in part 7 of subtitle B of title I of the Act affects or 
    modifies the provisions of section 514 of the Act with respect to group 
    health plans.
        (c) Special rules--(1) In general. Subject to paragraph (c)(2) of 
    this section, the provisions of part 7 of subtitle B of title I of the 
    Act relating to health insurance coverage offered by a health insurance 
    issuer supersede any provision of State law which establishes, 
    implements, or continues in effect a standard or requirement applicable 
    to imposition of a preexisting condition exclusion specifically 
    governed by section 701 which differs from the standards or 
    requirements specified in such section.
        (2) Exceptions. Only in relation to health insurance coverage 
    offered by a health insurance issuer, the provisions of this part do 
    not supersede any provision of State law to the extent that such 
    provision--
        (i) Shortens the period of time from the ``6-month period'' 
    described in section 701(a)(1) of the Act and Sec. 2590.701-3(a)(1)(i) 
    (for purposes of identifying a preexisting condition);
        (ii) Shortens the period of time from the ``12 months'' and ``18 
    months'' described in section 701(a)(2) of the Act and Sec. 2590.701-
    3(a)(1)(ii) (for purposes of applying a preexisting condition exclusion 
    period);
        (iii) Provides for a greater number of days than the ``63 day 
    period'' described in sections 701(c)(2)(A) and (d)(4)(A) of the Act 
    and Secs. 2590.701-3(a)(1)(iii) and 2590.701-4 (for purposes of 
    applying the break in coverage rules);
        (iv) Provides for a greater number of days than the ``30-day 
    period'' described in sections 701 (b)(2) and (d)(1) of the Act and 
    Sec. 2590.701-3(b) (for purposes of the enrollment period and 
    preexisting condition exclusion periods for certain newborns and 
    children that are adopted or placed for adoption);
        (v) Prohibits the imposition of any preexisting condition exclusion 
    in cases not described in section 701(d) of the Act or expands the 
    exceptions described therein;
        (vi) Requires special enrollment periods in addition to those 
    required under section 701(f) of the Act; or
        (vii) Reduces the maximum period permitted in an affiliation period 
    under section 701(g)(1)(B) of the Act.
        (d) Definitions--(1) State law. For purposes of this Sec. 2590.736 
    the term State law includes all laws, decisions, rules, regulations, or 
    other State action having the effect of law, of any State. A law of the 
    United States applicable only to the District of Columbia is treated as 
    a State law rather an a law of the United States.
        (2) State. For purposes of this section the term State includes a 
    State, the Northern Mariana Islands, any political subdivisions of a 
    State or such Island, or any agency or instrumentality of either.
    
    
    Sec. 2590.732  Special rule relating to group health plans.
    
        (a) General exception for certain small group health plans. The 
    requirements of this part 7 of subtitle B of title I of the Act do not 
    apply to any group health plan (and group health insurance coverage 
    offered in connection with a group health plan) for any plan year if, 
    on the first day of the plan year, the plan has fewer than 2 
    participants who are current employees.
        (b) Excepted benefits--(1) In general. The requirements of subparts 
    A and C of this part do not apply to any group health plan (or any 
    group health insurance coverage offered in connection with a group 
    health plan) in relation to its provision of the benefits
    
    [[Page 16954]]
    
    described in paragraph (b)(92), (3), (4), or (5) of this section (or 
    any combination of these benefits).
        (2) Benefits excepted in all circumstances. The following benefits 
    are excepted in all circumstances--
        (i) Coverage only for accident (including accidental death and 
    dismemberment);
        (ii) Disability income insurance;
        (iii) Liability insurance, including general liability insurance 
    and automobile liability insurance;
        (iv) Coverage issued as a supplement to liability insurance;
        (v) Workers' compensation or similar insurance;
        (vi) Automobile medical payment insurance;
        (vii) Credit-only insurance (for example, mortgage insurance); and
        (viii) Coverage for on-site medical clinics.
        (3) Limited excepted benefits--(i) In general. Limited-scope dental 
    benefits, limited-scope vision benefits, or long-term care benefits are 
    excepted if they are provided under a separate policy, certificate, or 
    contract of insurance, or are otherwise not an integral part of the 
    plan, as defined in paragraph (b)(3)(ii) of this section.
        (ii) Integral. For purposes of paragraph (b)(3)(i) of this section, 
    benefits are deemed to be an integral part of a plan unless a 
    participant has the right to elect not to receive coverage for the 
    benefits and, if the participant elects to receive coverage for the 
    benefits, the participant pays an additional premium or contribution 
    for that coverage.
        (iii) Limited scope. Limited scope dental or vision benefits are 
    dental or vision benefits that are sold under a separate policy or 
    rider and that are limited in scope to a narrow range or type of 
    benefits that are generally excluded from hospital/medical/surgical 
    benefit packages.
        (iv) Long-term care. Long-term care benefits are benefits that are 
    either--
        (A) Subject to State long-term care insurance laws;
        (B) For qualified long-term care insurance services, as defined in 
    section 7702B(c)(1) of the Code, or provided under a qualified long-
    term care insurance contract, as defined in section 7702B(b) of the 
    Internal Revenue Code; or
        (C) Based on cognitive impairment or a loss of functional capacity 
    that is expected to be chronic.
        (4) Noncoordinated benefits--(i) Excepted benefits that are not 
    coordinated. Coverage for only a specified disease or illness (for 
    example, cancer-only policies) or hospital indemnity or other fixed 
    dollar indemnity insurance (for example, $100/day) is excepted only if 
    it meets each of the conditions specified in paragraph (b)(4)(ii) of 
    this section.
        (ii) Conditions. Benefits are described in paragraph (b)(4)(i) of 
    this section only if--
        (A) The benefits are provided under a separate policy, certificate, 
    or contract of insurance;
        (B) There is no coordination between the provision of the benefits 
    and an exclusion of benefits under any group health plan maintained by 
    the same plan sponsor; and
        (C) The benefits are paid with respect to an event without regard 
    to whether benefits are provided with respect to the event under any 
    group health plan maintained by the same plan sponsor.
        (5) Supplemental benefits. The following benefits are excepted only 
    if they are provided under a separate policy, certificate, or contract 
    of insurance:
        (i) Medicare supplemental health insurance (as defined under 
    section 1882(g)(1) of the Social Security Act; also known as Medigap or 
    MedSupp insurance);
        (ii) Coverage supplemental to the coverage provided under Chapter 
    55, Title 10 of the United States Code (also known as CHAMPUS 
    supplemental programs), and
        (iii) Similar supplemental coverage provided to coverage under a 
    group health plan.
        (c) Treatment of partnerships. [Reserved]
    
    
    Sec. 2590.734  Enforcement. [Reserved]
    
    
    Sec. 2590.736  Effective dates.
    
        (a) General effective dates--(1) Non-collectively-bargained plans. 
    Except as otherwise provided in this section, part 7 of subtitle B of 
    title I of the Act and subparts A and C of this part apply with respect 
    to group health plans, including health insurance issuers offering 
    health insurance coverage in connection with group health plans, for 
    plan years beginning after June 30, 1997.
        (2) Collectively bargained plans. Except as otherwise provided in 
    this section (other than paragraph (a)(1) of this section), in the case 
    of a group health plan maintained pursuant to one or more collective 
    bargaining agreements between employee representatives and one or more 
    employers ratified before August 21, 1996, Part 7 of subtitle B of 
    title I of the Act and subparts A and C of this part do not apply to 
    plan years beginning before the later of July 1, 1997, or the date on 
    which the last of the collective bargaining agreements relating to the 
    plan terminates (determined without regard to any extension thereof 
    agreed to after August 21, 1996). For these purposes, any plan 
    amendment made pursuant to a collective bargaining agreement relating 
    to the plan, that amends the plan solely to conform to any requirement 
    of such part, is not treated as a termination of the collective 
    bargaining agreement.
        (3)(i) Preexisting condition exclusion periods for current 
    employees. Any preexisting condition exclusion period permitted under 
    Sec. 2590.701-3 is measured from the individual's enrollment date in 
    the plan. Such exclusion period, as limited under Sec. 2590.701-3, may 
    be completed prior to the effective date of the Health Insurance 
    Portability and Accountability Act of 1996 (HIPAA) for his or her plan. 
    Therefore, on the date the individual's plan becomes subject to part 7 
    of subtitle B of title I of the Act, no preexisting condition exclusion 
    may be imposed with respect to an individual beyond the limitation of 
    Sec. 2590.701-3. For an individual who has not completed the permitted 
    exclusion period under HIPAA, upon the effective date for his or her 
    plan, the individual may use creditable coverage that the individual 
    had prior to the enrollment date to reduce the remaining preexisting 
    condition exclusion period applicable to the individual.
        (ii) Examples. The following examples illustrate the rules of this 
    paragraph (a)(3):
    
        Example 1. (i) Individual A has been working for Employer X and 
    has been covered under Employer X's plan since March 1, 1997. Under 
    Employer X's plan, as in effect before January 1, 1998, there is no 
    coverage for any preexisting condition. Employer X's plan year 
    begins on January 1, 1998. A's enrollment date in the plan is March 
    1, 1997 and A has no creditable coverage before this date.
        (ii) In this Example 1, Employer X may continue to impose the 
    preexisting condition exclusion under the plan through February 28, 
    1998 (the end of the 12-month period using anniversary dates).
        Example 2. (i) Same facts as in Example 1, except that A's 
    enrollment date was August 1, 1996, instead of March 1, 1997.
        (ii) In this Example 2, on January 1, 1998, Employer X's plan 
    may no longer exclude treatment for any preexisting condition that A 
    may have; however, because Employer X's plan is not subject to HIPAA 
    until January 1, 1998, A is not entitled to claim reimbursement for 
    expenses under the plan for treatments for any preexisting condition 
    of A received before January 1, 1998.
    
        (b) Effective date for certification requirement--(1) In general. 
    Subject to the transitional rule in Sec. 2590.701-5(a)(5)(iii), the 
    certification rules of
    
    [[Page 16955]]
    
    Sec. 2590.701-5 apply to events occurring on or after July 1, 1996.
        (2) Period covered by certificate. A certificate is not required to 
    reflect coverage before July 1, 1996.
        (3) No certificate before June 1, 1997. Notwithstanding any other 
    provision of subpart A or C of this part, in no case is a certificate 
    required to be provided before June 1, 1997.
        (c) Limitation on actions. No enforcement action is to be taken, 
    pursuant to part 7 of subtitle B of title I of the Act, against a group 
    health plan or health insurance issuer with respect to a violation of a 
    requirement imposed by part 7 of subtitle B of title I of the Act 
    before January 1, 1998, if the plan or issuer has sought to comply in 
    good faith with such requirements. Compliance with this part is deemed 
    to be good faith compliance with the requirements of part 7 of subtitle 
    B of title I of the Act.
        (d) Transition rules for counting creditable coverage. An 
    individual who seeks to establish creditable coverage for periods 
    before July 1, 1996 is entitled to establish such coverage through the 
    presentation of documents or other means in accordance with the 
    provisions of Sec. 2590.701-5(c). For coverage relating to an event 
    occurring before July 1, 1996, a group health plan and a health 
    insurance issuer is not subject to any penalty or enforcement action 
    with respect to the plan's or issuer's counting (or not counting) such 
    coverage if the plan or issuer has sought to comply in good faith with 
    the applicable requirements under Sec. 2590.701-5(c).
        (e) Transition rules for certificates of creditable coverage--(1) 
    Certificates only upon request. For events occurring on or after July 
    1, 1996, but before October 1, 1996, a certificate is required to be 
    provided only upon a written request by or on behalf of the individual 
    to whom the certificate applies.
        (2) Certificates before June 1, 1997. For events occurring on or 
    after October 1, 1996 and before June 1, 1997, a certificate must be 
    furnished no later than June 1, 1997, or any later date permitted under 
    Sec. 2590.701-5(a)(2) (ii) and (iii).
        (3) Optional notice--(i) In general. This paragraph (e)(3) applies 
    with respect to events described in Sec. 2590.701-5(a)(5)(ii), that 
    occur on or after October 1, 1996 but before June 1, 1997. A group 
    health plan or health insurance issuer offering group health coverage 
    is deemed to satisfy Sec. 2590.701-5(a) (2) and (3) if a notice is 
    provided in accordance with the provisions of paragraphs (e)(3) (i) 
    through (iv) of this section.
        (ii) Time of notice. The notice must be provided no later than June 
    1, 1997.
        (iii) Form and content of notice. A notice provided pursuant to 
    this paragraph (e)(3) must be in writing and must include information 
    substantially similar to the information included in a model notice 
    authorized by the Secretary. Copies of the model notice are available 
    on the following website--http://www.dol.gov/dol/pwba/ (or call 1-800-
    998-7542).
        (iv) Providing certificate after request. If an individual requests 
    a certificate following receipt of the notice, the certificate must be 
    provided at the time of the request as set forth in Sec. 2590.701-
    5(a)(5)(iii).
        (v) Other certification rules apply. The rules set forth in 
    Sec. 2590.701-5(a)(4)(i) (method of delivery) and Sec. 2590.701-5(a)(1) 
    (entities required to provide a certificate) apply with respect to the 
    provision of the notice.
    
        Signed at Washington, D.C., this 27 day of March, 1997.
    Olena Berg,
    Assistant Secretary, Pension and Welfare Benefits Administration, U.S. 
    Department of Labor.
    
    Department of Health and Human Services
    
    45 CFR Subtitle A
    
        45 CFR is amended as set forth below:
        1. The heading for subtitle A is revised to read as follows:
    
    SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
        2. Existing parts 1 through 100 are designated as subchapter A of 
    subtitle A and a new subchapter heading is added to read as follows:
    
    SUBCHAPTER A--GENERAL ADMINISTRATION
    
        3. New subchapter B, consisting of parts 140 through 199, is added 
    to read as follows:
    
    SUBCHAPTER B--REQUIREMENTS RELATING TO HEALTH CARE ACCESS
    
    PARTS 140--143 [RESERVED]
    
    PART 144--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
    
    Subpart A--General Provisions
    
    Sec.
    144.101  Basis and purpose.
    144.102  Scope and applicability.
    144.103  Definitions applicable to both group (45 CFR Part 146) and 
    individual (45 CFR Part 148) markets.
    
    Subpart B--[Reserved]
    
        Authority: Secs. 2701 through 2763, 2791, and 2792 of the Public 
    Health Service Act, 42 U.S.C. 300gg through 300gg-63, 300gg-91, and 
    300gg-92.
    
    PART 144--REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
    
    Subpart A--General Provisions
    
    
    Sec. 144.101  Basis and purpose.
    
        Part 146 of this subchapter implements sections 2701 through 2723 
    of the Public Health Service Act (PHS Act, 42 U.S.C. 300gg, et seq.). 
    Its purpose is to improve access to group health insurance coverage and 
    to guarantee the renewability of all coverage in the group market. Part 
    148 of this subchapter implements sections 2741 through 2763 of the PHS 
    Act. Its purpose is to improve access to individual health insurance 
    coverage for certain eligible individuals who previously had group 
    coverage, and to guarantee the renewability of all coverage in the 
    individual market. Sections 2791 and 2792 of the PHS Act define terms 
    used in the regulations in this subchapter and provide the basis for 
    issuing these regulations, respectively.
    
    
    Sec. 144.102   Scope and applicability.
    
        (a) For purposes of 45 CFR parts 144 through 148, all health 
    insurance coverage is generally divided into two markets--the group 
    market (set forth in 45 CFR part 146) and the individual market (set 
    forth in 45 CFR part 148). 45 CFR part 146 limits the group market to 
    insurance sold to employment-related group health plans and further 
    divides the group market into the large group market and the small 
    group market. Federal law further defines the small group market as 
    insurance sold to employer plans with 2 to 50 employees. State law, 
    however, may expand the definition of the small group market to include 
    certain coverage that would otherwise, under the Federal law, be 
    considered coverage in the large group market or the individual market.
        (b) The protections afforded under 45 CFR parts 144 through 148 to 
    individuals and employers (and other sponsors of health insurance 
    offered in connection with a group health plan) are determined by 
    whether the coverage involved is obtained in the small group market, 
    the large group market, or the individual market. Small employers, and 
    individuals who are eligible to enroll under the employer's plan, are 
    guaranteed availability of insurance coverage sold in the small group 
    market. Small and large employers are guaranteed the right to renew 
    their group coverage, subject to certain
    
    [[Page 16956]]
    
    exceptions. Eligible individuals are guaranteed availability of 
    coverage sold in the individual market, and all coverage in the 
    individual market must be guaranteed renewable.
        (c) Coverage that is provided to associations, but is not related 
    to employment, is not considered group coverage under 45 CFR parts 144 
    through 148. The coverage is considered coverage in the individual 
    market, regardless of whether it is considered group coverage under 
    State law.
    
    
    Sec. 144.103   Definitions applicable to both group (45 CFR part 146) 
    and individual (45 CFR part 148) markets.
    
        Unless otherwise provided, the following definitions apply:
        Affiliation period means a period of time that must expire before 
    health insurance coverage provided by an HMO becomes effective, and 
    during which the HMO is not required to provide benefits.
        Applicable State authority means, with respect to a health 
    insurance issuer in a State, the State insurance commissioner or 
    official or officials designated by the State to enforce the 
    requirements of 45 CFR parts 146 and 148 for the State involved with 
    respect to the issuer.
        Beneficiary has the meaning given the term under section 3(8) of 
    the Employee Retirement Income Security Act of 1974 (ERISA), which 
    states, ``a person designated by a participant, or by the terms of an 
    employee benefit plan, who is or may become entitled to a benefit'' 
    under the plan.
        Bona fide association means, with respect to health insurance 
    coverage offered in a State, an association that meets the following 
    conditions:
        (1) Has been actively in existence for at least 5 years.
        (2) Has been formed and maintained in good faith for purposes other 
    than obtaining insurance.
        (3) Does not condition membership in the association on any health 
    status-related factor relating to an individual (including an employee 
    of an employer or a dependent of any employee).
        (4) Makes health insurance coverage offered through the association 
    available to all members regardless of any health status-related factor 
    relating to the members (or individuals eligible for coverage through a 
    member).
        (5) Does not make health insurance coverage offered through the 
    association available other than in connection with a member of the 
    association.
        (6) Meets any additional requirements that may be imposed under 
    State law.
        Church plan means a Church plan within the meaning of section 3(33) 
    of ERISA.
        COBRA definitions:
        (1) COBRA means Title X of the Consolidated Omnibus Budget 
    Reconciliation Act of 1985, as amended.
        (2) COBRA continuation coverage means coverage, under a group 
    health plan, that satisfies an applicable COBRA continuation provision.
        (3) COBRA continuation provision means sections 601 through 608 of 
    the Employee Retirement Income Security Act of 1974, section 4980B of 
    the Internal Revenue Code of 1986 (other than paragraph (f)(1) of 
    section 4980B insofar as it relates to pediatric vaccines), and Title 
    XXII of the PHS Act.
        (4) Continuation coverage means coverage under a COBRA continuation 
    provision or a similar State program. Coverage provided by a plan that 
    is subject to a COBRA continuation provision or similar State program, 
    but that does not satisfy all the requirements of that provision or 
    program, will be deemed to be continuation coverage if it allows an 
    individual to elect to continue coverage for a period of at least 18 
    months. Continuation coverage does not include coverage under a 
    conversion policy required to be offered to an individual upon 
    exhaustion of continuation coverage, nor does it include continuation 
    coverage under the Federal Employees Health Benefits Program.
        (5) Exhaustion of COBRA continuation coverage means that an 
    individual's COBRA continuation coverage ceases for any reason other 
    than either failure of the individual to pay premiums on a timely 
    basis, or for cause (such as making a fraudulent claim or an 
    intentional misrepresentation of a material fact in connection with the 
    plan). An individual is considered to have exhausted COBRA continuation 
    coverage if such coverage ceases--
        (i) Due to the failure of the employer or other responsible entity 
    to remit premiums on a timely basis; or
        (ii) When the individual no longer resides, lives, or works in a 
    service area of an HMO or similar program (whether or not within the 
    choice of the individual) and there is no other COBRA continuation 
    coverage available to the individual.
        (6) Exhaustion of continuation coverage means that an individual's 
    continuation coverage ceases for any reason other than either failure 
    of the individual to pay premiums on a timely basis, or for cause (such 
    as making a fraudulent claim or an intentional misrepresentation of a 
    material fact in connection with the plan). An individual is considered 
    to have exhausted continuation coverage if--
        (i) Coverage ceases due to the failure of the employer or other 
    responsible entity to remit premiums on a timely basis, or
        (ii) When the individual no longer resides, lives, or works in a 
    service area of an HMO or similar program (whether or not within the 
    choice of the individual) and there is no other continuation coverage 
    available to the individual.
        Condition means a medical condition.
        Creditable coverage has the meaning of 45 CFR 146.113(a).
        Eligible individual, for purposes of--
        (1) The group market provisions in 45 CFR part 146, subpart E, the 
    term is defined in 45 CFR 146.150(b); and
        (2) The individual market provisions in 45 CFR part 148, the term 
    is defined in 45 CFR 148.103.
        Employee has the meaning given the term under section 3(6) of 
    ERISA, which states, ``any individual employed by an employer.''
        Employer has the meaning given the term under section 3(5) of 
    ERISA, which states, ``any person acting directly as an employer, or 
    indirectly in the interest of an employer, in relation to an employee 
    benefit plan; and includes a group or association of employers acting 
    for an employer in such capacity.''
        Enroll means to become covered for benefits under a group health 
    plan (that is, when coverage becomes effective), without regard to when 
    the individual may have completed or filed any forms that are required 
    in order to enroll in the plan. For this purpose, an individual who has 
    health insurance coverage under a group health plan is enrolled in the 
    plan regardless of whether the individual elects coverage, the 
    individual is a dependent who becomes covered as a result of an 
    election by a participant, or the individual becomes covered without an 
    election.
        Enrollment date definitions (enrollment date and first day of 
    coverage) are set forth in 45 CFR 146.11(a)(2)(i) and (a)(2)(ii).
        ERISA stands for the Employee Retirement Income Security Act of 
    1974, as amended (29 U.S.C. 1001 et seq.).
        Excepted benefits for purposes of the--
        (1) Group market provisions in 45 CFR part 146 subpart D, the term 
    is defined in 45 CFR 146.145(b); and
        (2) The individual market provisions in 45 CFR part 148, the term 
    is defined in 45 CFR 148.220.
        Federal government plan means a governmental plan established or 
    maintained for its employees by the Government of the United States or 
    by
    
    [[Page 16957]]
    
    any agency or instrumentality of such Government.
        Genetic information means information about genes, gene products, 
    and inherited characteristics that may derive from the individual or a 
    family member. This includes information regarding carrier status and 
    information derived from laboratory tests that identify mutations in 
    specific genes or chromosomes, physical medical examinations, family 
    histories, and direct analysis of genes or chromosomes.
        Governmental plan means a governmental plan within the meaning of 
    section 3(32) of ERISA.
        Group health insurance coverage means health insurance coverage 
    offered in connection with a group health plan.
        Group health plan means an employee welfare benefit plan (as 
    defined in section 3(1) of ERISA) to the extent that the plan provides 
    medical care (as defined in section 2791(a)(2) of the PHS Act and 
    including items and services paid for as medical care) to employees or 
    their dependents (as defined under the terms of the plan) directly or 
    through insurance, reimbursement, or otherwise.
        Group market means the market for health insurance coverage offered 
    in connection with a group health plan. (However, unless otherwise 
    provided under State law, certain very small plans may be treated as 
    being in the individual market, rather than the group market; see the 
    definition of ``individual market'' in this section.)
        Health insurance coverage means benefits consisting of medical care 
    (provided directly, through insurance or reimbursement, or otherwise) 
    under any hospital or medical service policy or certificate, hospital 
    or medical service plan contract, or HMO contract offered by a health 
    insurance issuer.
        Health insurance issuer or issuer means an insurance company, 
    insurance service, or insurance organization (including an HMO) that is 
    required to be licensed to engage in the business of insurance in a 
    State and that is subject to State law that regulates insurance (within 
    the meaning of section 514(b)(2) of ERISA). This term does not include 
    a group health plan.
        Health maintenance organization or HMO means--
        (1) A Federally qualified health maintenance organization (as 
    defined in section 1301(a) of the PHS Act);
        (2) An organization recognized under State law as a health 
    maintenance organization; or
        (3) A similar organization regulated under State law for solvency 
    in the same manner and to the same extent as such a health maintenance 
    organization.
        Health status-related factor means health status, medical condition 
    (including both physical and mental illnesses), claims experience, 
    receipt of health care, medical history, genetic information, evidence 
    of insurability (including conditions arising out of acts of domestic 
    violence) and disability.
        Individual health insurance coverage means health insurance 
    coverage offered to individuals in the individual market, but does not 
    include short-term, limited-duration insurance. Individual health 
    insurance coverage can include dependent coverage.
        Indiviual market means the market for health insurance coverage 
    offered to individuals other than in connection with a group health 
    plan. Unless a State elects otherwise in accordance with section 
    2791(e)(1)(B)(ii) of the PHS Act, such term also includes coverage 
    offered in connection with a group health plan that has fewer than two 
    participants as current employees on the first day of the plan year.
        Internal Revenue Code (Code) means the Internal Revenue Code of 
    1986, as amended (Title 26, United States Code).
        Issuer means a health insurance issuer.
        Large employer means, in connection with a group health plan with 
    respect to a calendar year and a plan year, an employer who employed an 
    average of at least 51 employees on business days during the preceding 
    calendar year and who employs at least 2 employees on the first day of 
    the plan year, unless otherwise provided under State law.
        Large group market means the health insurance market under which 
    individuals obtain health insurance coverage (directly or through any 
    arrangement) on behalf of themselves (and their dependents) through a 
    group health plan maintained by a large employer, unless otherwise 
    provided under State law.
        Late enrollment definitions (late enrollee and late enrollment) are 
    set forth in 45 CFR 146.111 (a)(2)(iii) and (a)(2)(iv).
        Medical care or condition means amounts paid for any of the 
    following:
        (1) The diagnosis, cure, mitigation, or prevention of disease, or 
    amounts paid for the purpose of affecting any structure or function of 
    the body.
        (2) Transportation primarily for and essential to medical care 
    referred to in paragraph (1) of this definition.
        (3) Insurance covering medical care referred to in paragraphs (1) 
    and (2) of this definition.
        Medical condition means any condition, whether physical or mental, 
    including, but not limited to, any condition resulting from illness, 
    injury (whether or not the injury is accidental), pregnancy, or 
    congenital malformation. However, genetic information is not a 
    condition.
        NAIC stands for the National Association of Insurance 
    Commissioners.
        Network plan means health insurance coverage of a health insurance 
    issuer under which the financing and delivery of medical care 
    (including items and services paid for as medical care) are provided, 
    in whole or in part, through a defined set of providers under contract 
    with the issuer.
        Non-Federal governmental plan means a governmental plan that is not 
    a Federal government plan.
        Participant has the meaning given the term under section 3(7) of 
    ERISA, which states, ``any employee or former employee of an employer, 
    or any member or former member of an employee organization, who is or 
    may become eligible to receive a benefit of any type from an employee 
    benefit plan which covers employees of such employer or members of such 
    organization, or whose beneficiaries may be eligible to receive any 
    such benefit.''
        PHS Act stands for the Public Health Service Act.
        Placement, or being placed, for adoption means the assumption and 
    retention of a legal obligation for total or partial support of a child 
    by a person with whom the child has been placed in anticipation of the 
    child's adoption. The child's placement for adoption with the person 
    terminates upon the termination of the legal obligation.
        Plan sponsor has the meaning given the term under section 3(16)(B) 
    of ERISA, which states ``(i) the employer in the case of an employee 
    benefit plan established or maintained by a single employer, (ii) the 
    employee organization in the case of a plan established or maintained 
    by an employee organization, or (iii) in the case of a plan established 
    or maintained by two or more employers or jointly by one or more 
    employers and one or more employee organizations, the association, 
    committee, joint board of trustees, or other similar group of 
    representatives of the parties who establish or maintain the plan.''
        Plan year means the year that is designated as the plan year in the 
    plan document of a group health plan, except that if the plan document 
    does not designate a plan year or if there is no plan document, the 
    plan year is:
        (1) THe deductible/limit year used under the plan.
    
    [[Page 16958]]
    
        (2) If the plan does not impose deductibles or limits on a yearly 
    basis, the plan year is the policy year.
        (3) If the plan does not impose deductibles or limits on a yearly 
    basis, and either the plan is not insured or the insurance policy is 
    not renewed on an annual basis, the plan year is the employer's taxable 
    year.
        (4) In any other case, the plan year is the calendar year.
        Preexisting condition exclusion means a limitation or exclusion of 
    benefits relating to a condition based on the fact that the condition 
    was present before the first day of coverage, whether or not any 
    medical advice, diagnosis, care, or treatment was recommended or 
    received before that day. A preexisting condition exclusion includes 
    any inclusion applicable to an individual as a result of information 
    that is obtained relating to an individual's health status before the 
    individual's first day of coverage, such as a condition identified as a 
    result of a pre-enrollment questionnaire or physical examination given 
    to the individual, or review of medical records relating to the pre-
    enrollment period.
        Public health plan means ``public health plan'' within the meaning 
    of 45 CFR 146.113(a)(1)(ix).
        Short-term limited duration insurance means health insurance 
    coverage provided under a contract with an issuer that has an 
    expiration date specified in the contract (taking into account any 
    extensions that may be elected by the policyholder without the issuer's 
    consent) that is within 12 months of the date the contract becomes 
    effective.
        Significant break in coverage has the meaning given the term in 45 
    CFR 146.113(b)(2)(iii).
        Small employer means, in connection with a group health plan with 
    respect to a calendar year and a plan year, an employer who employed an 
    average of at least 2 but not more than 50 employees on business days 
    during the preceding calendar year and who employs at least 2 employees 
    on the first day of the plan year, unless otherwise provided under 
    State law.
        Small group market means the health insurance market under which 
    individuals obtain health insurance coverage (directly or through any 
    arrangement) on behalf of themselves (and their dependents) through a 
    group health plan maintained by a small employer.
        Special enrollment date has the meaning given the term in 45 CFR 
    146.117(d).
        State means each of the several States, the District of Columbia, 
    Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern 
    Mariana Islands.
        State health benefits risk pool means a ``State health benefits 
    risk pool'' within the meaning of 45 CFR 146.113(a)(1)(vii).
        Waiting period means the period that must pass before an employee 
    or dependent is eligible to enroll under the terms of a group health 
    plan. If an employee or dependent enrolls as a late enrollee or on a 
    special enrollment date, any period before such late or special 
    enrollment is not a waiting period. If an individual seeks and obtains 
    coverage in the individual market, any period after the date the 
    individual files a substantially complete application for coverage and 
    before the first day of coverage is a waiting period.
    
    Subpart B--[Reserved]
    
    PART 145--[RESERVED]
    
    PART 146--REQUIREMENTS FOR THE GROUP HEALTH INSURANCE MARKET
    
    Subpart A--General Provisions
    
    Sec.
    146.101 Basis and scope.
    
    Subpart B--Requirements Relating to Access and Renewability of 
    Coverage, and Limitations on Preexisting Condition Exclusion Periods
    
    Sec.
    146.111 Limitations on preexisting condition exclusion period.
    146.113 Rules relating to creditable coverage.
    146.115 Certification and disclosure of previous coverage.
    146.117 Special enrollment periods.
    146.119 HMO affiliation period as alternative to preexisting 
    condition exclusion.
    146.121 Prohibiting discrimination against participants and 
    beneficiaries based on health status-related factors.
    146.125 Effective dates.
    
    Subpart C--[Reserved]
    
    Subpart D--Preemption and Special Rules
    
    Sec.
    146.143 Preemption; State flexibility; construction.
    146.145 Special rules relating to group health plans.
    
    Subpart E--Provisions Applicable to Only Health Insurance Issuers
    
    Sec.
    146.150 Guaranteed availability of coverage for employers in the 
    small group market.
    146.152 Guaranteed renewability of coverage for employers in the 
    group market.
    146.160 Disclosure of information.
    
    Subpart F--Exclusion of Plans and Enforcement
    
    Sec.
    146.180 Treatment of non-Federal governmental plans.
    146.184 Enforcement.
    
        Authority: Secs. 2701 through 2763, 2791, and 2792 of the PHS 
    Act, 42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92.
    
    PART 146--REQUIREMENTS FOR THE GROUP HEALTH INSURANCE MARKET
    
    Subpart A--General Provisions
    
    
    Sec. 146.101  Basis and scope.
    
        (a) Statutory basis. This part implements sections 2701 through 
    2723 of the PHS Act. Its purpose is to improve access to group health 
    insurance coverage and to guarantee the renewability of all coverage in 
    the group market. Sections 2791 and 2792 of the PHS Act define terms 
    used in the regulations in this subchapter and provide the basis for 
    issuing these regulations, respectively.
        (b) Scope. A group health plan or health insurance issuer offering 
    group health insurance coverage may provide greater rights to 
    participants and beneficiaries than those set forth in this part.
        (1) Subpart B. Subpart B of this part sets forth minimum 
    requirements for group health plans and health insurance issuers 
    offering group health insurance coverage concerning:
        (i) Limitations on a preexisting condition exclusion period.
        (ii) Certificates and disclosure of previous coverage.
        (iii) Methods of counting creditable coverage.
        (iv) Special enrollment periods.
        (v) Use of an affiliation period by an HMO as an alternative to a 
    preexisting condition exclusion.
        (2) Subpart D. Subpart D of this part sets forth exceptions to the 
    requirements of Subpart B for certain plans and certain types of 
    benefits.
        (3) Subpart E. Subpart E of this part implements sections 2711 
    through 2713 of the PHS Act, which set forth requirements that apply 
    only to health insurance issuers offering health insurance coverage, in 
    connection with a group health plan.
        (4) Subpart F. Subpart F of this part addresses the treatment of 
    non-Federal governmental plans, and sets forth enforcement procedures.
    
    [[Page 16959]]
    
    Subpart B--Requirements Relating to Access and Renewability of 
    Coverage, and Limitations on Preexisting Condition Exclusion 
    Periods
    
    
    Sec. 146.111  Limitations on preexisting condition exclusion period.
    
        (a) Preexisting condition exclusion--(1) General. Subject to 
    paragraph (b) of this section, a group health plan, and a health 
    insurance issuer offering group health insurance coverage, may impose, 
    with respect to a participant or beneficiary, a preexisting condition 
    exclusion only if the requirements of this paragraph (a) are satisfied.
        (1) 6-month look-back rule. A preexisting condition exclusion must 
    relate to a condition (whether physical or mental), regardless of the 
    cause of the condition, for which medical advice, diagnosis, care, or 
    treatment was recommended or received within the 6-month period ending 
    on the enrollment date.
        (A) For purposes of this paragraph (a)(1)(i), medical advice, 
    diagnosis, care, or treatment is taken into account only if it is 
    recommended by, or received from, an individual licensed or similarly 
    authorized to provide such services under State law and operating 
    within the scope of practice authorized by State law.
        (B) For purposes of this paragraph (a)(1)(i), the 6-month period 
    ending on the enrollment date begins on the 6-month anniversary date 
    preceding the enrollment date. For example, for an enrollment date of 
    August 1, 1998, the 6-month period preceding the enrollment date is the 
    period commencing on February 1, 1998 and continuing through July 31, 
    1998. As another example, for an enrollment date of August 30, 1998, 
    the 6-month period preceding the enrollment date is the period 
    commencing on February 28, 1998 and continuing through August 29, 1998.
        (C) The following examples illustrate the requirements of this 
    paragraph (a)(1)(i).
    
        Example 1: (i) Individual A is treated for a medical condition 7 
    months before the enrollment date in Employer R's group health plan. 
    As part of such treatment, A's physician recommends that a follow-up 
    examination be given 2 months later. Despite this recommendation, A 
    does not receive a follow-up examination and no other medical 
    advice, diagnosis, care, or treatment for that condition is 
    recommended to A or received by A during the 6-month period ending 
    on A's enrollment date in Employer R's plan.
        (ii) In this Example, Employer R's plan may not impose a 
    preexisting condition exclusion period with respect to the condition 
    for which A received treatment 7 months prior to the enrollment 
    date.
        Example 2: (i) Same facts as Example 1 except that Employer R's 
    plan learns of the condition and attaches a rider to A's policy 
    excluding coverage for the condition. Three months after enrollment, 
    A's condition recurs, and Employer R's plan denies payment under the 
    rider.
        (ii) In this Example, the rider is a preexisting condition 
    exclusion and Employer R's plan may not impose a preexisting 
    condition exclusion with respect to the condition for which A  
    received treatment 7 months prior to the enrollment date.
        Example 3: (i) Individual B has asthma and is treated for that 
    condition several times during the 6-month period before B's 
    enrollment date in Employer S's plan. The plan imposes a 12-month 
    preexisting condition exclusion. B has no prior creditable coverage 
    to reduce the exclusion period. Three months after the enrollment 
    date, B begins coverage under Employer S's plan. B is hospitalized 
    for asthma.
        (ii) In this Example, Employer S's plan may exclude payment for 
    the hospital stay and the physician services associated with this of 
    illness because the care is related to a medical condition for which 
    treatment was received by B during the 6-month period before the 
    enrollment date.
        Example 4: (i) Individual D, who is subject to a preexisting 
    condition exclusion imposed by Employer U's plan, has diabetes, as 
    well as a foot condition caused by poor circulation and retinal 
    degeneration (both of which are conditions that may be directly 
    attributed to diabetes). After enrolling in the plan, D  stumbles 
    and breaks a leg.
        (ii) In this Example, the leg fracture is not a condition 
    related to D's diabetes, even though poor circulation in D's 
    extremities and poor vision may have contributed towards the 
    accident. However, any additional medical services that may be 
    needed because of D's preexisting diabetic condition that would not 
    be needed by another patient with a broken leg who does not have 
    diabetes may be subject to the preexisting condition exclusion 
    imposed under Employer U's plan.
    
        (ii) Maximum length of preexisting condition exclusion (the look-
    forward rule). A preexisting condition exclusion is not permitted to 
    extend for more than 12 months (18 months in the case of a late 
    enrollee) after the enrollment date. For purposes of this paragraph 
    (a)(1)(ii), the 12-month and 18-month periods after the enrollment date 
    are determined by reference to the anniversary of the enrollment date. 
    For example, for an enrollment date of August 1, 1998, the 12-month 
    period after the enrollment date is the period commencing on August 1, 
    1998 and continuing through July 31, 1999.
        (iii) Reducing a preexisting condition exclusion period by 
    creditable coverage. The period of any preexisting condition exclusion 
    that would otherwise apply to an individual under a group health plan 
    is reduced by the number of days of creditable coverage the individual 
    has as of the enrollment date, as counted under Sec. 146.113. For 
    purposes of this part, the phrase ``days of creditable coverage'' has 
    the same meaning as the phrase ``the aggregate of the periods of 
    creditable coverage'' as such term is used in section 2701(a)(3) of the 
    PHS Act.
        (iv) Other standards. See Sec. 146.121 for other standards that may 
    apply with respect to certain benefit limitations or restrictions under 
    a group health plan.
        (2) Enrollment definitions--(i) Enrollment date means the first day 
    of coverage or, if there is a waiting period, the first day of the 
    waiting period.
        (ii) (A) First day of coverage means, in the case of an individual 
    covered for benefits under a group health plan in the group market, the 
    first day of coverage under the plan and, in the case of an individual 
    covered by health insurance coverage in the individual market, the 
    first day of coverage under the policy.
        (B) Example. The following example illustrates the requirements of 
    paragraph (a)(2)(ii)(A) of this section:
    
        Example: (i) Employer V's group health plan provides for 
    coverage to begin on the first day of the first payroll period 
    following the date an employee is hired and completes the applicable 
    enrollment forms, or on any subsequent January 1 after completion of 
    the applicable enrollment forms. Employer V's plan imposes a 
    preexisting condition exclusion for 12 months (reduced by the 
    individual's creditable coverage) following an individual's 
    enrollment date. Employee E is hired by Employer V on October 13, 
    1998 and then on October 14, 1998 completes and files all the forms 
    necessary to enroll in the plan. E's coverage under the plan becomes 
    effective on October 25, 1998 (which is the beginning of the first 
    payroll period after E's date of hire).
        (ii) In this Example, E's enrollment date is October 13, 1998 
    (which is the first day of the waiting period for E's enrollment and 
    is also E's date of hire). Accordingly, with respect to E, the 6-
    month period in paragraph (a)(1)(i) would be the period from April 
    13, 1998 through October 12, 1998, the maximum permissible period 
    during which Employer V's plan could apply a preexisting condition 
    exclusion under paragraph (a)(1)(ii) would be the period from 
    October 13, 1998 through October 12, 1999, and this period would be 
    reduced under paragraph (a)(1)(iii) by E's days of creditable 
    coverage as of October 13, 1998.
    
        (iii) Late enrollee means an individual whose enrollment in a plan 
    is a late enrollment.
        (iv) Late enrollment means enrollment under a group health plan 
    other than on--
        (A) The earliest date on which coverage can become effective under 
    the terms of the plan; or
    
    [[Page 16960]]
    
        (B) A special enrollment date for the individual. If an individual 
    ceases to be eligible for coverage under the plan by terminating 
    employment, and subsequently becomes eligible for coverage under the 
    plan by resuming employment, only eligibility during the individual's 
    most recent period of employment is taken into account in determining 
    whether the individual is a late enrollee under the plan with respect 
    to the most recent period of coverage. Similar rules apply if an 
    individual again becomes eligible for coverage following a suspension 
    of coverage that applied generally under the plan.
        (v) Examples. The following examples illustrate the requirements of 
    this paragraph (a)(2):
    
        Example 1: (i) Employee F first becomes eligible to be covered 
    by Employer W's group health plan on January 1, 1999, but elects not 
    to enroll in the plan until April 1, 1999. April 1, 1999 is not a 
    special enrollment date for F. 
        (ii) In this Example, F would be a late enrollee with respect to 
    F's coverage that became effective under the plan on April 1, 1999.
        Example 2: (i) Same as Example 1, except that F does not enroll 
    in the plan on April 1, 1999 and terminates employment with Employer 
    W on July 1, 1999, without having had any health insurance coverage 
    under the plan. F is rehired by Employer W on January 1, 2000 and is 
    eligible for and elects coverage under Employer W's plan effective 
    on January 1, 2000.
        (ii) In this Example, F would not be a late enrollee with 
    respect to F's coverage that became effective on January 1, 2000.
    
        (b) Exceptions pertaining to preexisting condition exclusions--(1) 
    Newborns--(i) General rule. Subject to paragraph (b)(3) of this 
    section, a group health plan, and a health insurance issuer offering 
    group health insurance coverage, may not impose any preexisting 
    condition exclusion with regard to a child who, as of the last day of 
    the 30-day period beginning with the date of birth, is covered under 
    any creditable coverage. Accordingly, if a newborn is enrolled in a 
    group health plan (or other creditable coverage) within 30 days after 
    birth and subsequently enrolls in another group health plan without a 
    significant break in coverage, the other plan may not impose any 
    preexisting condition exclusion with regard to the child.
        (ii) Example. The following example illustrates the requirements of 
    this paragraph (b)(1).
    
        Example: (i) Seven months after enrollment in Employer W's group 
    health plan, Individual E has a child born with a birth defect. 
    Because the child is enrolled in Employer W's plan within 30 days of 
    birth, no preexisting condition exclusion may be imposed with 
    respect to the child under Employer W's plan. Three months after the 
    child's birth, E commences employment with Employer X and enrolls 
    with the child in Employer X's plan within 45 days of leaving 
    Employer W's plan. Employer X's plan imposes a 12-month exclusion 
    for any preexisting condition.
        (ii) In this Example, Employer X's plan may not impose any 
    preexisting condition exclusion with respect to E's child because 
    the child was covered within 30 days of birth and had no significant 
    break in coverage. This result applies regardless of whether E's 
    child is included in the certificate of creditable coverage provided 
    to E by Employer W indicating 300 days of dependent coverage or 
    receives a separate certificate indicating 90 days of coverage. 
    Employer X's plan may impose a preexisting condition exclusion with 
    respect to E for up to 2 months for any preexisting condition of E 
    for which medical advice, diagnosis, care, or treatment was 
    recommended or received by E within the 6-month period ending on E's 
    enrollment date in Employer X's plan.
    
        (2) Adopted Children. Subject to paragraph (b)(3) of this section, 
    a group health plan, and a health insurance issuer offering group 
    health insurance coverage, may not impose any preexisting condition 
    exclusion in the case of a child who is adopted or placed for adoption 
    before attaining 18 years of age and who, as of the last day of the 30-
    day period beginning on the date of the adoption or placement for 
    adoption, is covered under creditable coverage. This rule does not 
    apply to coverage before the date of such adoption or placement for 
    adoption.
        (3) Break in coverage. Paragraphs (b)(1) and (b)(2) of this section 
    no longer apply to a child after a significant break in coverage.
        (4) Pregnancy. A group health plan, and a health insurance issuer 
    offering group health insurance coverage, may not impose a preexisting 
    condition exclusion relating to pregnancy as a preexisting condition.
        (5) Special enrollment dates. For special enrollment dates relating 
    to new dependents, see Sec. 146.117(b).
        (c) Notice of plan's preexisting condition exclusion. A group 
    health plan, and health insurance issuer offering group health 
    insurance under the plan, may not impose a preexisting condition 
    exclusion with respect to a participant or dependent of the participant 
    before notifying the participant, in writing, of the existence and 
    terms of any preexisting condition exclusion under the plan and of the 
    rights of individuals to demonstrate creditable coverage (and any 
    applicable waiting periods) as required by Sec. 146.115. The 
    description of the rights of individuals to demonstrate creditable 
    coverage includes a description of the right of the individual to 
    request a certificate from a prior plan or issuer, if necessary, and a 
    statement that the current plan or issuer will assist in obtaining a 
    certificate from any prior plan or issuer, if necessary.
    
    
    Sec. 146.113  Rules relating to creditable coverage.
    
        (a) General rules)--(1) Creditable coverage. For purposes of this 
    section, except as provided in paragraph (a)(2), the term creditable 
    coverage means coverage of an individual under any of the following:
        (i) A group health plan as defined in Sec. 144.103.
        (ii) Health insurance coverage as defined in Sec. 144.103 (whether 
    or not the entity offering the coverage is subject to the requirements 
    of this part and 45 CFR part 148, and without regard to whether the 
    coverage is offered in the group market, the individual market, or 
    otherwise).
        (iii) Part A or part B of title XVIII of the Social Security Act 
    (Medicare).
        (iv) Title XIX of the Social Security Act (Medicaid), other than 
    coverage consisting solely of benefits under section 1928 of the Social 
    Security Act (the program for distribution of pediatric vaccines).
        (v) Title 10 U.S.C. Chapter 55 (medical and dental care for members 
    and certain former members of the uniformed services, and for their 
    dependents; for purposes of title 10 U.S.C. chapter 55, ``uniformed 
    services'' means the armed forces and the Commissioned Corps of the 
    National Oceanic and Atmospheric Administration and of the Public 
    Health Service).
        (vi) A medical care program of the Indian Health Service or of a 
    tribal organization.
        (vii) A State health benefits risk pool. For purposes of this 
    section, a State health benefits risk pool means--
        (A) An organization qualifying under section 501(c)(26) of the 
    Code;
        (B) A qualified high risk pool described in section 2744(c)(2) of 
    the PHS Act; or
        (C) Any other arrangement sponsored by a State, the membership 
    composition of which is specified by the State and which is established 
    and maintained primarily to provide health insurance coverage for 
    individuals who are residents of such State and who, by reason of the 
    existence or history of a medical condition--
        (1) Are unable to acquire medical care coverage for such condition 
    through insurance or from an HMO; or
        (2) Are able to acquire such coverage only at a rate which is 
    substantially in
    
    [[Page 16961]]
    
    excess of the rate for such coverage through the membership 
    organization.
        (viii) A health plan offered under title 5 U.S.C. chapter 89 (the 
    Federal Employees Health Benefits Program).
        (ix) A public health plan. For purposes of this section, a public 
    health plan means any plan established or maintained by a State, 
    county, or other political subdivision of a State that provides health 
    insurance coverage to individuals who are enrolled in the plan.
        (x) A health benefit plan under section 5(e) of the Peace Corps Act 
    (22 U.S.C. 2504(e)).
        (2) Excluded coverage. Creditable coverage does not include 
    coverage consisting solely of coverage of excepted benefits (described 
    in Sec. 146.145).
        (3) Methods of counting creditable coverage. For purposes of 
    reducing any preexisting condition exclusion period, as provided under 
    Sec. 146.111(a)(1)(iii), a group health plan, and a health insurance 
    issuer offering group health insurance coverage, determines the amount 
    of an individual's creditable coverage by using the standard method 
    described in paragraph (b), except that the plan, or issuer, may use 
    the alternative method under paragraph (c) with respect to any or all 
    of the categories of benefits described under paragraph (c)(3).
        (b) Standard method--(1) Specific benefits not considered. Under 
    the standard method, a group health plan, and a health insurance issuer 
    offering group health insurance coverage, determines the amount of 
    creditable coverage without regard to the specific benefits included in 
    the coverage.
        (2) Counting creditable coverage--(i) Based on days. For purposes 
    of reducing the preexisting condition exclusion period, a group health 
    plan, and a health insurance issuer offering group health insurance 
    coverage, determines the amount of creditable coverage by counting all 
    the days that the individual has under one or more types of creditable 
    coverage. Accordingly, if on a particular day, an individual has 
    creditable coverage from more than one source, all the creditable 
    coverage on that day is counted as one day. Further, any days in a 
    waiting period for a plan or policy are not creditable coverage under 
    the plan or policy.
        (ii) Days not counted before significant break in coverage. Days of 
    creditable coverage that occur before a significant break in coverage 
    are not required to be counted.
        (iii) Definition of significant break in coverage. A significant 
    break in coverage means a period of 63 consecutive days during all of 
    which the individual does not have any creditable coverage, except that 
    neither a waiting period nor an affiliation period is taken into 
    account in determining a significant break in coverage. (See section 
    731(b)(2)(iii) of ERISA and section 2723(b)(2)(iii) of the PHS Act, 
    which exclude from preemption State insurance laws that require a break 
    of more than 63 days before an individual has a significant break in 
    coverage for purposes of State law.)
        (iv) Examples. The following examples illustrate how creditable 
    coverage is counted in reducing preexisting condition exclusion 
    periods:
    
        Example 1: (i) Individual A work for Employer P and has 
    creditable coverage under Employer P's plan for 18 months before A's 
    employment terminates. A is hired by Employer O, and enrolls in 
    Employer O's group health plan, 64 days after the last date of 
    coverage under Employer P's plan. Employer O's plan has a 12-month 
    preexisting condition exclusion period.
        (ii) In this Example, because A had a break in coverage of 63 
    days, Employer O's plan may disregard A's prior coverage and A may 
    be subject to a 12-month preexisting condition exclusion period.
        Example 2: (i) Same facts as Example 1, except that A is hired 
    by Employer O, and enrolls in Employer O's plan, on the 63rd day 
    after the last date of coverage under Employer P's plan.
        (ii) In this Example, A has a break in coverage of 62 days. 
    Because A's break in coverage is not a significant break in 
    coverage, Employer O's plan must count A's prior creditable coverage 
    for purposes of reducing the plan's preexisting condition exclusion 
    period as it applies to A.
        Example 3: (i) Same facts as Example 1, except that Employer O's 
    plan provides benefits through an insurance policy that, as required 
    by applicable State insurance laws, defines a significant break in 
    coverage as 90 days.
        (ii) In this Example, the issuer that provides group health 
    insurance to Employer O's plan must count A's period of creditable 
    coverage prior to the 63-day break.
        Example 4: (i) Same facts as Example 3, except that Employer O's 
    plan is a self-insured plan, and thus is not subject to State 
    insurance laws.
        (ii) In this Example, the plan is not governed by the longer 
    break rules under State insurance law and A's previous coverage may 
    be disregarded.
        Example 5: (i) Individual B begins employment with Employer R 45 
    days after terminating coverage under a prior group health plan. 
    Employer R's group health plan has a 30-day waiting period before 
    coverage begins. B enrolls in Employer R's plan when first eligible.
        (ii) In this Example, B does not have a significant break in 
    coverage for purposes of determining whether B's prior coverage must 
    be counted by Employer R's plan. B has only a 44-day break in 
    coverage because the 30-day waiting period is not taken into account 
    in determining a significant break in coverage.
        Example 6: (i) Individual C works for Employer S and has 
    creditable coverage under Employer S's plan for 200 days before C's 
    employment is terminated and coverage ceases. C is then unemployed 
    for 51 days before being hired by Employer T. Employer T's plan has 
    a 3-month waiting period. C works for Employer T for 2 months and 
    then terminates employment. Eleven days after terminating employment 
    with Employer T, C begins working for Employer U. Employer U's plan 
    has no waiting period, but has a 6-month preexisting condition 
    exclusion period.
        (ii) In this Example, C does not have a significant break in 
    coverage because, after disregarding the waiting period under 
    Employer T's plan, C had only a 62-day break in coverage (51 days 
    plus 11 days). Accordingly, C has 200 days of creditable coverage 
    and Employer U's plan may not apply its 6-month preexisting 
    condition exclusion period with respect to C.
        Example 7: (i) Individual D terminates employment with Employer 
    V on January 13, 1998 after being covered for 24 months under 
    Employer V's group health plan. On March 17, the 63rd day without 
    coverage, D applies for a health insurance policy in the individual 
    market. D's application is accepted and the coverage is made 
    effective May 1.
        (ii) In this Example, because D applied for the policy before 
    the end of the 63rd day, and coverage under the policy ultimately 
    became effective, the period between the date of application and the 
    first day of coverage is a waiting period, and no significant break 
    in coverage occurred even though the actual period without coverage 
    was 107 days.
        Example 8: (i) Same facts as Example 7, except that D's 
    application for a policy in the individual market is denied.
        (ii) In this Example, because D did not obtain coverage 
    following application, D incurred a significant break in coverage on 
    the 64th day.
    
        (v) Other permissible counting methods--(A) General rule. 
    Notwithstanding any other provisions of this paragraph (b)(2), for 
    purposes of reducing a preexisting condition exclusion period (but not 
    for purposes of issuing a certificate under Sec. 146.115), a group 
    health plan, and a health insurance issuer offering group health 
    insurance coverage, may determine the amount of creditable coverage in 
    any other manner that is at least as favorable to the individual as the 
    method set forth in this paragraph (b)(2), subject to the requirements 
    of other applicable law.
        (B) Example. The following example illustrates the requirements of 
    this paragraph (b)(2)(v):
    
        Example: (1) Individual F has coverage under group health plan Y 
    from January 3, 1997 through March 25, 1997. F then becomes covered 
    by group health plan Z. F's enrollment date in Plan Z is May 1, 
    1997. Plan Z has a 12-month preexisting condition exclusion period.
        (ii) In this Example, Plan Z may determine, in accordance with 
    the rules prescribed in
    
    [[Page 16962]]
    
    paragraph (b)(2) (i), (ii), and (iii), that F has 82 days of 
    creditable coverage (29 days in January, 28 days in February, and 25 
    days in March). Thus, the preexisting condition exclusion period 
    will no longer apply to F on February 8, 1998 (82 days before the 
    12-month anniversary of F's enrollment (May 1)). For administrative 
    convenience, however, Plan Z may consider that the preexisting 
    condition exclusion period will no longer apply to F on the first 
    day of the month (February 1).
    
        (c) Alternative method--(1) Specific benefits considered. Under the 
    alternative method, a group health plan, or a health insurance issuer 
    offering group health insurance coverage, determines the amount of 
    creditable coverage based on coverage within any category of benefits 
    described in paragraph (c)(3) and not based on coverage for any other 
    benefits. The plan or issuer may use the alternative method for any or 
    all of the categories. The plan may apply a different preexisting 
    condition exclusion period with respect to each category (and may apply 
    a different preexisting condition exclusion period for benefits that 
    are not within any category). The creditable coverage determined for a 
    category of benefits applies only for purposes of reducing the 
    preexisting condition exclusion period with respect to that category. 
    An individual's creditable coverage for benefits that are not within 
    any category for which the alternative method is being used is 
    determined under the standard method of paragraph (b).
        (2) Uniform application. A plan or issuer using the alternative 
    method is required to apply it uniformly to all participants and 
    beneficiaries under the plan or policy. The use of the alternative 
    method is set forth in the plan.
        (3) Categories of benefits. The alternative method for counting 
    creditable coverage may be used for coverage for any of the following 
    categories of benefits:
        (i) Mental health.
        (ii) Substance abuse treatment.
        (iii) Prescription drugs.
        (iv) Dental care.
        (v) Vision care.
        (4) Plan notice. If the alternative method is used, the plan is 
    required to--
        (i) State prominently that the plan is using the alternative method 
    of counting creditable coverage in disclosure statements concerning the 
    plan, and state this to each enrollee at the time of enrollment under 
    the plan; and
        (ii) Include in these statements a description of the effect of 
    using the alternative method, including an identification of the 
    categories used.
        (5) Issuer notice. With respect to health insurance coverage 
    offered by an issuer in the small or large group market, if the 
    insurance coverage uses the alternative method, the issuer states 
    prominently in any disclosure statement concerning the coverage, and to 
    each employer at the time of the offer or sale of the coverage, that 
    the issuer is using the alternative method, and include in such 
    statements a description of the effect of using the alternative method. 
    This applies separately to each type of coverage offered by the health 
    insurance issuer.
        (6) Disclosure of information on previous benefits. See 
    Sec. 146.115(b) for special rules concerning disclosure of coverage to 
    a plan, or issuer, using the alternative method of counting creditable 
    coverage under this paragraph (c).
        (7) Counting creditable coverage--(i) General. Under the 
    alternative method, the group health plan or issuer counts creditable 
    coverage within a category if any level of benefits is provided within 
    the category. Coverage under a reimbursement account or arrangement, 
    such as a flexible spending arrangement, (as defined in section 
    106(c)(2) of the Internal Revenue Code), does not constitute coverage 
    within any category.
        (ii) Special rules. In counting an individual's creditable coverage 
    under the alternative method, the group health plan, or issuer, first 
    determines the amount of the individual's creditable coverage that may 
    be counted under paragraph (b), up to a total of 365 days of the most 
    recent creditable coverage (546 days for a late enrollee). The period 
    over which this creditable coverage is determined is referred to as the 
    ``determination period.'' Then, for the category specified under the 
    alternative method, the plan or issuer counts within the category all 
    days of coverage that occurred during the determination period (whether 
    or not a significant break in coverage for that category occurs), and 
    reduces the individual's preexisting condition exclusion period for 
    that category by that number of days. The plan or issuer may determine 
    the amount of creditable coverage in any other reasonable manner, 
    uniformly applied, that is at least as favorable to the individual.
        (iii) Example. The following example illustrates the requirements 
    of this paragraph (c)(7):
    
        Example: (i) Individual D enrolls in Employer V's plan on 
    January 1, 2001. Coverage under the plan includes prescription drug 
    benefits. On April 1, 2001, the plan ceases providing prescription 
    drug benefits. D's employment with Employer V ends on January 1, 
    2002, after D was covered under Employer V's group health plan for 
    365 days. D enrolls in Employer Y's plan on February 1, 2001 (D's 
    enrollment date). Employer Y's plan uses the alternative method of 
    counting creditable coverage and imposes a 12-month preexisting 
    condition exclusion on prescription drug benefits.
        (ii) In this Example, Employer Y's plan may impose a 275-day 
    preexisting condition exclusion with respect to D for prescription 
    drug benefits because D had the equivalent of 90-days of creditable 
    coverage relating to prescription drug benefits within D's 
    determination period.
    
    
    Sec. 146.115  Certification and disclosure of previous coverage.
    
        (a) Certificate of creditable coverage--(1) Entities required to 
    provide certificate--(i) General. A group health plan, and each health 
    insurance issuer offering group health insurance coverage under a group 
    health plan, is required to certificates of creditable coverage in 
    accordance with this paragraph (a).
        (ii) Duplicate certificates not required. An entity required to 
    provide a certificate under this paragraph (a)(1) for an individual is 
    deemed to have satisfied the certification requirements for that 
    individual if another party provides the certificate, but only to the 
    extent that information relating to the individual's creditable 
    coverage and waiting or affiliation period is provided by the other 
    party. For example, in the case of a group health plan funded through 
    an insurance policy, the issuer is deemed to have satisfied the 
    certification requirement with respect to a participant or beneficiary 
    if the plan actually provides a certificate that includes the 
    information required under paragraph (a)(3) with respect to the 
    participant or beneficiary.
        (iii) Special rule for group health plan. To the extent coverage 
    under a plan consists of group health insurance coverage, the plan is 
    deemed to have satisfied the certification requirements under this 
    paragraph (a)(1) if any issuer offering the coverage is required to 
    provide the certificates pursuant to an agreement between the plan and 
    the issuer. For example, if there is an agreement between an issuer and 
    the plan sponsor under which the issuer agrees to provide certificates 
    for individuals covered under the plan, and the issuer fails to provide 
    a certificate to an individual when the plan would have been required 
    to provide one under this paragraph (a), then the issuer, but not the 
    plan, violates the certification requirements of this paragraph (a).
        (iv) Special rules for issuers--(A) Responsibility of issuer for 
    coverage period--(1) General rule. An issuer is
    
    [[Page 16963]]
    
    not required to provide information regarding coverage provided to an 
    individual by another party.
        (2) Example. The following example illustrates the requirements of 
    this paragraph (a)(1)(iv)(A):
    
        Example. (i) A plan offers coverage with an HMO option from one 
    issuer and an indemnity option from a different issuer. The HMO has 
    not entered into an agreement with the plan to provide certificates 
    as permitted under paragraph (a)(1)(iii) of this section.
        (ii) In this Example, if an employee switches from the indemnity 
    option to the HMO option and later ceases to be covered under the 
    plan, any certificate provided by the HMO is not required to provide 
    information regarding the employee's coverage under the indemnity 
    option.
    
        (B) Cessation of issuer coverage prior to cessation of coverage 
    under a plan--(1) General rule. If an individual's coverage under an 
    issuer's policy ceases before the individual's coverage under the plan 
    ceases, the issuer is required to provide sufficient information to the 
    plan (or to another party designated by the plan) to enable a 
    certificate to be provided by the plan (or other party), after 
    cessation of the individual's coverage under the plan, that reflects 
    the period of coverage under the policy. The provision of that 
    information to the plan will satisfy the issuer's obligation to provide 
    an automatic certificate for that period of creditable coverage for the 
    individual under paragraphs (a)(2)(ii) and (a)(3) of this section. In 
    addition, an issuer providing that information is required to cooperate 
    with the plan in responding to any request made under paragraph (b)(2) 
    of this section (relating to the alternative method of counting 
    creditable coverage). If the individual's coverage under the plan 
    ceases at the time the individual's coverage under the issuer's policy 
    ceases, the issuer must provide an automatic certificate under 
    paragraph (a)(2)(ii) of this section. An issuer may presume that an 
    individual whose coverage ceases at a time other than the effective 
    date for changing enrollment options has ceased to be covered under the 
    plan.
        (2) Example. The following example illustrates the requirements of 
    this paragraph (a)(1)(iv)(B):
        Example: (i) A group health plan provides coverage under an HMO 
    option and an indemnity option with a different issuer, and only 
    allows employees to switch on each January 1. Neither the HMO nor 
    the indemnity issuer has entered into an agreement with the plan to 
    provide automatic certificates as permitted under paragraph 
    (a)(2)(ii) of this section.
        (ii) In this Example, if an employee switches from the indemnity 
    option to the HMO option on January 1, the issuer must provide the 
    plan (or a person designated by the plan) with appropriate 
    information with respect to the individual's coverage with the 
    indemnity issuer. However, if the individual's coverage with the 
    indemnity issuer ceases at a date other than January 1, the issuer 
    is instead required to provide the individual with an automatic 
    certificate.
    
        (2) Individuals for whom a certificate must be provided; timing of 
    issuance--(i) Individuals. A certificate must be provided, without 
    charge, for participants or dependents who are or were covered under a 
    group health plan upon the occurrence of any of the events described in 
    paragraph (a)(2)(ii) and (a)(2)(iii) of this section.
        (ii) Issuance of automatic certificates. The certificates described 
    in this paragraph (a)(2)(ii) of this section are referred to as 
    ``automatic certificates.''
        (A) Qualified beneficiaries upon a qualifying event. In the case of 
    an individual who is a qualified beneficiary (as defined in section 
    607(3) of ERISA, section 4980B(g)(1) of the Code, or section 2208 of 
    the PHS Act) entitled to elect COBRA continuation coverage, an 
    automatic certificate is required to be provided at the time the 
    individual would lose coverage under the plan in the absence of COBRA 
    continuation coverage or alternative coverage elected instead of COBRA 
    continuation coverage. A plan or issuer satisfies this requirement if 
    it provides the automatic certificate no later than the time a notice 
    is required to be furnished for a qualifying event under section 606 of 
    the Act, section 4980B(f)(6) of the Code and section 2206 of the PHS 
    Act (relating to notices required under COBRA).
        (B) Other individuals when coverage ceases. In the case of an 
    individual who is not a qualified beneficiary entitled to elect COBRA 
    continuation coverage, an automatic certificate is required to be 
    provided at the time the individual ceases to be covered under the 
    plan. A plan or issuer satisfies this requirement if it provides the 
    automatic certificate within a reasonable time period thereafter. In 
    the case of an individual who is entitled to elect to continue coverage 
    under a State program similar to COBRA and who receives the automatic 
    certificate not later than the time a notice is required to be 
    furnished under the State program, the certificate is deemed to be 
    provided within a reasonable time period after the cessation of 
    coverage under the plan.
        (C) Qualified beneficiaries when COBRA ceases. In the case of an 
    individual who is a qualified beneficiary and has elected COBRA 
    continuation coverage (or whose coverage has continued after the 
    individual became entitled to elect COBRA continuation coverage), an 
    automatic certificate is to be provided at the time the individual's 
    coverage under the plan ceases. A plan, or issuer, satisfies this 
    requirement if it provides the automatic certificate within a 
    reasonable time after coverage ceases (or after the expiration of any 
    grace period for nonpayment of premiums). An automatic certificate is 
    required to be provided to such an individual regardless of whether the 
    individual has previously received an automatic certificate under 
    paragraph (a)(2)(ii)(A) of this section.
        (iii) Any individual upon request. Requests for certificates are 
    permitted to be made by, or on behalf of, an individual within 24 
    months after coverage ceases. Thus, for example, a plan in which an 
    individual enrolls may, if authorized by the individual, request a 
    certificate of the individual's creditable coverage on behalf of the 
    individual from a plan in which the individual was formerly enrolled. 
    After the request is received, a plan or issuer is required to provide 
    the certificate by the earliest date that the plan or issuer, acting in 
    a reasonable or prompt fashion can provide the certificate. A 
    certificate is to be provided under this paragraph (a)(2)(iii) even if 
    the individual has previously received a certificate under this 
    paragraph (a)(2)(iii) or an automatic certificate under paragraph 
    (a)(2)(ii) of this section.
        (iv) Examples. The following examples illustrate the requirements 
    of this paragraph (a)(2).
    
        Example 1: (i) Individual A terminates employment with Employer 
    O. A is a qualified beneficiary entitled to elect COBRA continuation 
    coverage under Employer O's group health plan. A notice of the 
    rights provided under COBRA is typically furnished to qualified 
    beneficiaries under the plan within 10 days after a covered employee 
    terminates employment.
        (ii) In this Example, the automatic certificate may be provided 
    at the same time that A is provided the COBRA notice.
        Example 2: (i) Same facts as Example 1, except that the 
    automatic certificate for A is not completed by the time the COBRA 
    notice is furnished to A.
        (ii) In this Example, the automatic certificate may be provided 
    within the period permitted by law for the delivery of notices under 
    COBRA.
        Example 3: (i) Employer R maintains an insured group health 
    plan. R has never had 20 employees and thus R's plan is not subject 
    to the COBRA continuation coverage provisions. However, R is in a 
    State that has a State program similar to COBRA. B terminates 
    employment with R and loses coverage under R's plan.
        (ii) In this Example, the automatic certificate may be provided 
    not later than the time a notice is required to be furnished under 
    the State program.
    
    [[Page 16964]]
    
        Example 4: (i) Individual C terminates employment with Employer 
    S and receives both a notice of C's rights under COBRA and an 
    automatic certificate. C elects COBRA continuation coverage under 
    Employer S's group health plan. After four months of COBRA 
    continuation coverage and the expiration of a 30-day grace period, 
    S's group health plan determines that C's COBRA continuation 
    coverage has ceased due to failure to make a timely payment for 
    continuation coverage.
        (ii) In this Example, the plan must provide an updated automatic 
    certificate to C within a reasonable time after the end of the grace 
    period.
        Example 5: (i) Individual D is currently covered under the group 
    health plan of Employer T. D requests a certificate, as permitted 
    under paragraph (a)(2)(iii). Under the procedure for Employer T's 
    plan, certificates are mailed (by first class mail) 7 business days 
    following receipt of the request. This date reflects the earliest 
    date that the plan, acting in a reasonable and prompt fashion, can 
    provide certificates.
        (ii) In this Example, the plan's procedure satisfies paragraph 
    (a)(2)(iii) of this section.
    
        (3) Form and content of certificate--(i) Written certificate--(A) 
    General. Except as provided in paragraph (a)(3)(i)(B) of this section, 
    the certificate must be provided in writing (including any form 
    approved by HCFA as a writing).
        (B) Other permissible forms. No written certificate is required to 
    be provided under this paragraph (a) with respect to a particular event 
    described in paragraphs (a)(2)(ii) and (a)(2)(iii) of this section if 
    all the following conditions are met:
        (1) An individual is entitled to receive a certificate.
        (2) The individual requests that the certificate be sent to another 
    plan or issuer instead of to the individual.
        (3) The plan or issuer that would otherwise receive the certificate 
    agrees to accept the information in paragraph (a)(3) through means 
    other than a written certificate (for example, by telephone).
        (4) The receiving plan or issuer receives the information from the 
    sending plan or issuer in such form within the time periods required 
    under paragraph (a)(2) of this section.
        (ii) Required information. The certificate must include all of the 
    following:
        (A) The date the certificate is issued.
        (B) The name of the group health plan that provided the coverage 
    described in the certificate.
        (C) The name of the participant or dependent with respect to whom 
    the certificate applies, and any other information necessary for the 
    plan providing the coverage specified in the certificate to identify 
    the individual, such as the individual's identification number under 
    the plan and the name of the participant if the certificate is for (or 
    includes) a dependent.
        (D) The name, address, and telephone number of the plan 
    administrator or issuer required to provide the certificate.
        (E) The telephone number to call for further information regarding 
    the certificate (if different from paragraph (a)(3)(ii)(D)).
        (F) Either--
        (1) A statement that an individual has at least 18 months (for this 
    purpose, 546 days is deemed to be 18 months) of creditable coverage, 
    disregarding days of creditable coverage before a significant break in 
    coverage, or
        (2) The date any waiting period (and affiliation period, if 
    applicable) began and the date creditable coverage began.
        (G) The date creditable coverage ended, unless the certificate 
    indicates that creditable coverage is continuing as of the date of the 
    certificate.
        (iii) Periods of coverage under certificate. If an automatic 
    certificate is provided under paragraph (a)(2)(ii) of this section, the 
    period that must be included on the certificate is the last period of 
    continuous coverage ending on the date coverage ceased. If an 
    individual requests a certificate under paragraph (a)(2)(iii) of this 
    section, a certificate must be provided for each period of continuous 
    coverage ending within the 24-month period ending on the date of the 
    request (or continuing on the date of the request). A separate 
    certificate may be provided for each such period of continuous 
    coverage.
        (iv) Combining information for families. A certificate may provide 
    information with respect to both a participant and the participant's 
    dependents if the information is identical for each individual or, if 
    the information is not identical, certificates may be provided on one 
    form if the form provides all the required information for each 
    individual and separately states the information that is not identical.
        (v) Model certificate. The requirements of paragraph (a)(3)(ii) of 
    this section are satisfied if the plan or issuer provides a certificate 
    in accordance with a model certificate authorized by HCFA.
        (vi) Excepted benefits; categories of benefits. No certificate is 
    required to be furnished with respect to excepted benefits described in 
    Sec. 146.145. In addition, the information in the certificate regarding 
    coverage is not required to specify categories of benefits described in 
    Sec. 146.113(c) (relating to the alternative method of counting 
    creditable coverage). However, if excepted benefits are provided 
    concurrently with other creditable coverage (so that the coverage does 
    not consist solely of excepted benefits), information concerning the 
    benefits may be required to be disclosed under paragraph (b) of this 
    section.
        (4) Procedures--(i) Method of delivery. The certificate is required 
    to be provided to each individual described in paragraph (a)(2) of this 
    section or an entity requesting the certificate on behalf of the 
    individual. The certificate may be provided by first-class mail. If the 
    certificate or certificates are provided to the participant and the 
    participant's spouse at the participant's last known address, then the 
    requirements of this paragraph (a)(4) are satisfied with respect to all 
    individuals residing at that address. If a dependent's last known 
    address is different than the participant's last known address, a 
    separate certificate is required to be provided to the dependent at the 
    dependent's last known address. If separate certificates are being 
    provided by mail to individuals who reside at the same address, 
    separate mailings of each certificate are not required.
        (ii) Procedure for requesting certificates. A plan or issuer must 
    establish a procedure for individuals to request and receive 
    certificates under paragraph (a)(2)(iii) of this section.
        (iii) Designated recipients. If an automatic certificate is 
    required to be provided under paragraph (a)(2)(ii) of this section, and 
    the individual entitled to receive the certificate designates another 
    individual or entity to receive the certificate, the plan or issuer 
    responsible for providing the certificate is permitted to provide the 
    certificate to the designated party. If a certificate is required to be 
    provided upon request under paragraph (a)(2)(iii) of this section and 
    the individual entitled to receive the certificate designates another 
    individual or entity to receive the certificate, the plan or issuer 
    responsible for providing the certificate is required to provide the 
    certificate to the designated party.
        (5) Special rules concerning dependent coverage--(i) Reasonable 
    efforts--(A) General rule. A plan or issuer is required to use 
    reasonable efforts to determine any information needed for a 
    certificate relating to the dependent coverage. In any case in which an 
    automatic certificate is required to be furnished with respect to a 
    dependent under paragraph (a)(2)(ii) of this section, no individual 
    certificate is required to be furnished until the plan or issuer knows 
    (or making reasonable efforts should know) of the
    
    [[Page 16965]]
    
    dependent's cessation of coverage under the plan.
        (B) Example. The following example illustrates the requirements of 
    this paragraph (a)(5)(i):
    
        Example: (i) A group health plan covers employees and their 
    dependents. The plan annually requests all employees to provide 
    updated information regarding dependents, including the specific 
    date on which an employee has a new dependent or on which a person 
    ceases to be a dependent of the employee.
        (ii) In this Example, the plan has satisfied the standard in 
    this paragraph (a)(5)(i) that it make reasonable efforts to 
    determine the cessation of dependents' coverage and the related 
    dependent coverage information.
    
        (ii) Special rules for demonstrating coverage. If a certificate 
    furnished by a plan or issuer does not provide the name of any 
    dependent of an individual covered by the certificate, the individual 
    may, if necessary, use the procedures described in paragraph (c)(4) of 
    this section for demonstrating dependent status. In addition, an 
    individual may, if necessary, use these procedures to demonstrate that 
    a child was enrolled within 30 days of birth, adoption, or placement 
    for adoption. See Sec. 146.111(b), under which such a child would not 
    be subject to a preexisting condition exclusion.
        (iii) Transition rule for dependent coverage through June 30, 
    1998--(A) General. A group health plan or health insurance issuer that 
    cannot provide the names of dependents (or related coverage 
    information) for purposes of providing a certificate of coverage for a 
    dependent may satisfy the requirements of paragraph (a)(3)(ii)(C) of 
    this section by providing the name of the participant covered by the 
    group health plan or health insurance issuer and specifying that the 
    type of coverage described in the certificate is for dependent coverage 
    (for example, family coverage or employee-plus-spouse coverage).
        (B) Certificates provided on request. For purposes of certificates 
    provided on the request of, or on behalf of, an individual under 
    paragraph (a)(2)(iii) of this section, a plan or issuer must make 
    reasonable efforts to obtain and provide the names of any dependent 
    covered by the certificate where such information is requested to be 
    provided. It does not include the name of any dependent of an 
    individual covered by the certificate, the individual may, if 
    necessary, use the procedures described in paragraph (c) of this 
    section for submitting documentation to establish that the creditable 
    coverage in the certificate applies to the dependent.
        (C) Demonstrating a dependent's creditable coverage. See paragraph 
    (c)(4) of this section for special rules to demonstrate dependent 
    status.
        (D) Duration. This paragraph (a)(5)(iii) is only effective for 
    certifications provided with respect to events occurring through June 
    30, 1998.
        (6) Special certification rules--(i) Issuers. Issuers of group and 
    individual health insurance are required to provide certificates of any 
    creditable coverage they provide in the group or individual health 
    insurance market, even if the coverage is provided in connection with 
    an entity or program that is not itself required to provide a 
    certificate because it is not subject to the group market provisions of 
    this part, part 7 of subtitle B of title I of ERISA, or chapter 100 of 
    subtitle K of the Internal Revenue Code. This would include coverage 
    provided in connection with any of the following:
        (A) Creditable coverage described in sections 2701 (c)(1)(G) 
    through (c)(1)(J) of the PHS Act (coverage under a State health 
    benefits risk pool, the Federal Employees Health Benefits Program, a 
    public health plan, and a health benefit plan under section 5(e) of the 
    Peace Corps Act),
        (B) Coverage subject to section 2721(b)(1)(B) of the PHS Act 
    (requiring certificates by issuers offering health insurance coverage 
    in connection with any group health plan, including a church plan or a 
    governmental plan (including the Federal Employees Health Benefits 
    Program (FEHBP)).
        (C) Coverage subject to section 2743 of the PHS Act applicable to 
    health insurance issuers in the individual market. (However, this 
    section does not require a certificate to be provided with respect to 
    short-term limited duration insurance, which is excluded from the 
    definition of ``individual health insurance coverage'' in 45 CFR 
    144.103 that is not provided in connection with a group health plan, as 
    described in paragraph (a)(6)(i)(B) of this section.)
        (ii) Other entities. For special rules requiring that certain other 
    entities, not subject to this part, provide certificates consistent 
    with the rules in this section, see section 2791(a)(3) of the PHS Act 
    applicable to entities described in sections 2701(c)(1)(C), (D), (E), 
    and (F) of the PHS Act (relating to Medicare, Medicaid, CHAMPUS, and 
    Indian Health Service), section 2721(b)(1)(A) of the PHS Act applicable 
    to non-Federal governmental plans generally, section 2721(b)(2)(C)(ii) 
    of the PHS Act applicable to non-Federal governmental plans that elect 
    to be excluded from the requirements of subparts 1 and 3 of part A of 
    title XXVII of the PHS Act, and section 9805(a) of the Internal Revenue 
    Code applicable to group health plans, which includes church plans (as 
    defined in section 414(e) of the Internal Revenue Code).
        (b) Disclosure of coverage to a plan, or issuer, using the 
    alternative method of counting creditable coverage--(1) General. If an 
    individual enrolls in a group health plan with respect to which the 
    plan, or issuer, uses the alternative method of counting creditable 
    coverage described in section 2701(c)(3)(B) of the PHS Act and 
    Sec. 146.113(c), the individual provides a certificate of coverage 
    under paragraph (a) of this section, and the plan or issuer in which 
    the individual enrolls so requests, the entity that issued the 
    certificate (the ``prior entity'') is required to disclose promptly to 
    a requesting plan or issuer (the ``requesting entity'') the information 
    set forth in paragraph (b)(2) of this section.
        (2) Information to be disclosed. The prior entity is required to 
    identify to the requesting entity the categories of benefits with 
    respect to which the requesting entity is using the alternative method 
    of counting creditable coverage, and the requesting entity may identify 
    specific information that the requesting entity reasonably needs in 
    order to determine the individual's creditable coverage with respect to 
    any such category. The prior entity is required to disclose promptly to 
    the requesting entity the creditable coverage information so requested.
        (3) Charge for providing information. The prior entity furnishing 
    the information under paragraph (b) of this section may charge the 
    requesting entity for the reasonable cost of disclosing such 
    information.
        (c) Ability of an individual to demonstrate creditable coverage and 
    waiting period information--(1) General. The rules in this paragraph 
    (c) implement section 2701(c)(4) of the PHS Act, which permits 
    individuals to establish creditable coverage through means other than 
    certificates, and section 2701(e)(3) of the PHS Act, which requires the 
    Secretary to establish rules designed to prevent an individual's 
    subsequent coverage under a group health plan or health insurance 
    coverage from being adversely affected by an entity's failure to 
    provide a certificate with respect to that individual. If the accuracy 
    of a certificate is contested or a certificate is unavailable when 
    needed by the individual, the individual has the right to demonstrate 
    creditable coverage (and waiting or affiliation periods) through the 
    presentation of documents or other means. For example, the individual 
    may make such a demonstration when--
    
    [[Page 16966]]
    
        (i) An entity has failed to provide a certificate within the 
    required time period;
        (ii) The individual has creditable coverage but an entity may not 
    be required to provide a certificate of the coverage under paragraph 
    (a) of this section;
        (iii) The coverage is for a period before July 1, 1996;
        (iv) The individual has an urgent medical condition that 
    necessitates a determination before the individual can deliver a 
    certificate to the plan; or
        (v) The individual lost a certificate that the individual had 
    previously received and is unable to obtain another certificate.
        (2) Evidence of creditable coverage--(i) Consideration of evidence. 
    A plan or issuer is required to take into account all information that 
    it obtains or that is presented on behalf of an individual to make a 
    determination, based on the relevant facts and circumstances, whether 
    an individual has creditable coverage and is entitled to offset all or 
    a portion of any preexisting condition exclusion period. A plan or 
    issuer shall treat the individual as having furnished a certificate 
    under paragraph (a) of this section if the individual attests to the 
    period of creditable coverage, the individual also presents relevant 
    corroborating evidence of some creditable coverage during the period, 
    and the individual cooperates with the plan's or issuer's efforts to 
    verify the individual's coverage. For this purpose, cooperation 
    includes providing (upon the plan's or issuer's request) a written 
    authorization for the plan or issuer to request a certificate on behalf 
    of the individual, and cooperating in efforts to determine the validity 
    of the corroborating evidence and the dates of creditable coverage. 
    While a plan or issuer may refuse to credit coverage where the 
    individual fails to cooperate with the plan's or issuer's efforts to 
    verify coverage, the plan or issuer may not consider an individual's 
    inability to obtain a certificate to be evidence of the absence of 
    creditable coverage.
        (ii) Documents. Documents that may establish creditable coverage 
    (and waiting periods or affiliation periods) in the absence of a 
    certificate include explanations of benefit claims (EOB) or other 
    correspondence from a plan or issuer indicating coverage, pay stubs 
    showing a payroll deduction for health coverage, a health insurance 
    identification card, a certificate of coverage under a group health 
    policy, records from medical care providers indicating health coverage, 
    third party statements verifying periods of coverage, and any other 
    relevant documents that evidence periods of health coverage.
        (iii) Other evidence. Creditable coverage (and waiting period or 
    affiliation period information) may also be established through means 
    other than documentation, such as by a telephone call from the plan or 
    provider to a third party verifying creditable coverage.
        (iv) Example. The following example illustrates the requirements of 
    this paragraph (c)(2):
    
        Example: (i) Employer X's group health plan imposes a 
    preexisting condition exclusion of 12 months on new enrollees under 
    the plan and uses the standard method of determining creditable 
    coverage. F fails to receive a certificate of prior coverage from 
    the self-insured group health plan maintained by F's prior employer, 
    Employer W, and requests a certificate. However, F (and Employer X's 
    plan, on F's behalf) is unable to obtain a certificate from Employer 
    W's plan. F attests that, to the best of F's knowledge, F had at 
    least 12 months of continuous coverage under Employer W's plan, and 
    that the coverage ended no earlier than F's termination of 
    employment from Employer W. In addition, F presents evidence of 
    coverage, such as an explanation of benefits for a claim that was 
    made during the relevant period.
        (ii) In this Example, based solely on these facts, F has 
    demonstrated creditable coverage for the 12 months of coverage under 
    Employer W's plan in the same manner as if F had presented a written 
    certificate of creditable coverage.
    
        (3) Demonstrating categories of creditable coverage. Procedures 
    similar to those described in this paragraph (c) apply in order to 
    determine an individual's creditable coverage with respect to any 
    category under paragraph (b) of this section (relating to determining 
    creditable coverage under the alternative method).
        (4) Demonstrating dependent status. If, in the course of providing 
    evidence (including a certificate) of creditable coverage, an 
    individual is required to demonstrate dependent status, the group 
    health plan or issuer is required to treat the individual as having 
    furnished a certificate showing the dependent status if the individual 
    attests to such dependency and the period of such status and the 
    individual cooperates with the plan's or issuer's efforts to verify the 
    dependent status.
        (d) Determination and notification of creditable coverage--(1) 
    Reasonable time period. In the event that a group health plan or health 
    insurance issuer offering group health insurance coverage receives 
    information in this section under paragraph (a) (certifications), 
    paragraph (b) (disclosure of information relating to the alternative 
    method), or paragraph (c) (other evidence of creditable coverage), the 
    entity is required, within a reasonable time period following receipt 
    of the information, to make a determination regarding the individual's 
    period of creditable coverage and notify the individual of the 
    determination in accordance with paragraph (d)(2) of this section. 
    Whether a determination and notification regarding an individual's 
    creditable coverage is made within a reasonable time period is 
    determined based on the relevant facts and circumstances. Relevant 
    facts and circumstances include whether a plan's application of a 
    preexisting condition exclusion would prevent an individual from having 
    access to urgent medical services.
        (2) Notification to individual of period of preexisting condition 
    exclusion. A plan or issuer seeking to impose a preexisting condition 
    exclusion is required to disclose to the individual, in writing, its 
    determination of any preexisting condition exclusion period that 
    applies to the individual, and the basis for such determination, 
    including the source and substance of any information on which the plan 
    or issuer relied. In addition, the plan or issuer is required to 
    provide the individual with a written explanation of any appeal 
    procedures established by the plan or issuer, and with a reasonable 
    opportunity to submit additional evidence of creditable coverage. 
    However, nothing in this paragraph (d) or paragraph (c) of this section 
    prevents a plan or issuer from modifying an initial determination of 
    creditable coverage if it determines that the individual did not have 
    the claimed creditable coverage, provided that--
        (i) A notice of the reconsideration is provided to the individual; 
    and
        (ii) Until the final determination is made, the plan or issuer, for 
    purposes of approving access to medical services (such as a pre-surgery 
    authorization), acts in a manner consistent with the initial 
    determination.
        (3) Examples. The following examples illustrate this paragraph (d):
    
        Example: (i) Individual F terminates employment with Employer W 
    and, a month later, is hired by Employer X. Example 1: Individual G 
    is hired by Employer Y. Employer Y's group health plan imposes a 
    preexisting condition exclusion for 12 months with respect to new 
    enrollees and uses the standard method of determining credible 
    coverage. Employer Y's plan determines that G is subject to a 4-
    month preexisting condition exclusion, based on a certificate of 
    creditable coverage that is provided by G to Employer Y's plan 
    indicating 8 months of coverage under G's prior group health plan.
    
    [[Page 16967]]
    
        (ii) In this Example, Employer Y's plan must notify G within a 
    reasonable period of time following receipt of the certificate that 
    G is subject to a 4-month preexisting condition exclusion beginning 
    on G's enrollment date in Y's plan.
        Example 2: (i) Same facts as in Example 1, except that Employer 
    Y's plan determines that G has 14 months of creditable coverage 
    based on G's certificate indicating 14 months of creditable coverage 
    under G's prior plan.
        (ii) In this Example, Employer Y's plan is not required to 
    notify G that G will not be subject to a preexisting condition 
    exclusion.
        Example 3: (i) Individual H is hired by Employer Z. Employer Z's 
    group health plan imposes a preexisting condition exclusion for 12 
    months with respect to new enrollees and uses the standard method of 
    determining creditable coverage. H develops an urgent health 
    condition before receiving a certificate of prior coverage. H 
    attests to the period of prior coverage, presents corroborating 
    documentation of the coverage period, and authorizes the plan to 
    request a certificate on H's behalf.
        (ii) In this Example, Employer Z's plan must review the evidence 
    presented by H. In addition, the plan must make a determination and 
    notify H regarding any preexisting condition exclusion period that 
    applies to H (and the basis of such determination) within a 
    reasonable time period following receipt of the evidence that is 
    consistent with the urgency of H's health condition (this 
    determination may be modified as permitted under paragraph (d)(2)).
    
    
    Sec. 146.117  Special enrollment periods.
    
        (a) Special enrollment for certain individuals who lose coverage--
    (1) General. A group health plan, and a health insurance issuer 
    offering group health insurance coverage in connection with a group 
    health plan, is required to permit employees and dependents described 
    in this section in paragraph (a)(2), (a)(3), or (a)(4) to enroll for 
    coverage under the terms of the plan if the conditions in paragraph 
    (a)(5) are satisfied and the enrollment is requested within the period 
    described in paragraph (a)(6). The enrollment is effective at the time 
    described in paragraph (a)(7). The special enrollment rights under this 
    paragraph (a) apply without regard to the dates on which an individual 
    would otherwise be able to enroll under the plan.
        (2) Special enrollment of an employee only. An employee is 
    described in this paragraph (a)(2) if the employee is eligible, but not 
    enrolled, for coverage under the terms of the plan and, when enrollment 
    was previously offered to the employee under the plan and was declined 
    by the employee, the employee was covered under another group health 
    plan or had other health insurance coverage.
        (3) Special enrollment of dependents only. A dependent is described 
    in this paragraph (a)(3) if the dependent is a dependent of an employee 
    participating in the plan, the dependent is eligible, but not enrolled, 
    for coverage under the terms of the plan, and, when enrollment was 
    previously offered under the plan and was declined, the dependent was 
    covered under another group health plan or had other health insurance 
    coverage.
        (4) Special enrollment of both employee and dependent. An employee 
    and any dependent of the employee are described in this paragraph 
    (a)(4) if they are eligible, but not enrolled, for coverage under the 
    terms of the plan and, when enrollment was previously offered to the 
    employee or dependent under the plan and was declined, the employee or 
    dependent was covered under another group health plan or had other 
    health insurance coverage.
        (5) Conditions for special enrollment. An employee or dependent is 
    eligible to enroll during a special enrollment period if each of the 
    following applicable conditions is met:
        (i) When the employee declined enrollment for the employee or the 
    dependent, the employee stated in writing that coverage under another 
    group health plan or other health insurance coverage was the reason for 
    declining enrollment. This paragraph (a)(5)(i) applies only if--
        (A) The plan required such a statement when the employee declined 
    enrollment; and
        (B) The employee is provided with notice of the requirement to 
    provide the statement in paragraph (a)(5)(i) (and the consequences of 
    the employee's failure to provide the statement) at the time the 
    employee declined enrollment.
        (ii) (A) When the employee declined enrollment for the employee or 
    dependent under the plan, the employee or dependent had COBRA 
    continuation coverage under another plan and COBRA continuation 
    coverage under that other plan has since been exhausted; or
        (B) If the other coverage that applied to the employee or dependent 
    when enrollment was declined was not under a COBRA continuation 
    provision, either the other coverage has been terminated as a result of 
    loss of eligibility for the coverage or employer contributions towards 
    the other coverage have been terminated. For this purpose, loss of 
    eligibility for coverage includes a loss of coverage as a result of 
    legal separation, divorce, death, termination of employment, reduction 
    in the number of hours of employment, and any loss of eligibility after 
    a period that is measured by reference to any of the foregoing. Thus, 
    for example, if an employee's coverage ceases following a termination 
    of employment and the employee is eligible for but fails to elect COBRA 
    continuation coverage, this is treated as a loss of eligibility under 
    this paragraph (a)(5)(ii)(B). However, loss of eligibility does not 
    include a loss due to failure of the individual or the participant to 
    pay premiums on a timely basis or termination of coverage for cause 
    (such as making a fraudulent claim or an intentional misrepresentation 
    of a material fact in connection with the plan). In addition, for 
    purposes of this paragraph (a)(5)(ii)(B), employer contributions 
    include contributions by any current or former employer (of the 
    individual or another person) that was contributing to coverage for the 
    individual.
        (6) Length of special enrollment period. The employee is required 
    to request enrollment (for the employee or the employee's dependent, as 
    described in this section in paragraph (a)(2), paragraph (a)(3), or 
    paragraph (a)(4)) not later than 30 days after the exhaustion of the 
    other coverage described in paragraph (a)(5)(ii)(A) or termination of 
    the other coverage as a result of the loss of eligibility for the other 
    coverage for items described in paragraph (a)(5)(ii)(B) or following 
    the termination of employer contributions toward that other coverage. 
    The plan may impose the same requirements that apply to employees who 
    are otherwise eligible under the plan to immediately request enrollment 
    for coverage (for example, that the request be made in writing).
        (7) Effective date of enrollment. Enrollment is effective not later 
    than the first day of the first calendar month beginning after the date 
    the completed request for enrollment is received.
        (b) Special enrollment with respect to certain dependent 
    beneficiaries--(1) General. A group health plan that makes coverage 
    available with respect to dependents of a participant is required to 
    provide a special enrollment period to permit individuals described in 
    this section in paragraph (b)(2), (b)(3), (b)(4), (b)(5), or (b)(6) to 
    be enrolled for coverage under the terms of the plan if the enrollment 
    is requested within the time period described in paragraph (b)(7). The 
    enrollment is effective at the time described in paragraph (b)(8). The 
    special enrollment rights under this paragraph (b) apply without regard 
    to the dates on which an individual would otherwise be able to enroll 
    under the plan.
        (2) Special enrollment of an employee who is eligible but not 
    enrolled. An individual is described in this paragraph (b)(2) if the 
    individual is an employee who is eligible, but not
    
    [[Page 16968]]
    
    enrolled, in the plan, the individual would be a participant but for a 
    prior election by the individual not to enroll in the plan during a 
    previous enrollment period, and a person becomes a dependent of the 
    individual through marriage, birth, or adoption or placement for 
    adoption.
        (3) Special enrollment of a spouse of a participant. An individual 
    is described in this paragraph (b)(3) if either--
        (i) The individual becomes the spouse of a participant; or
        (ii) The individual is a spouse of the participant and a child 
    becomes a dependent of the participant through birth, adoption, or 
    placement for adoption.
        (4) Special enrollment of an employee who is eligible but not 
    enrolled and the spouse of such employee. An employee who is eligible, 
    but not enrolled, in the plan, and an individual who is a dependent of 
    such employee, are described in this paragraph (b)(4) if the employee 
    would be a participant but for a prior election by the employee not to 
    enroll in the plan during a previous enrollment period, and either--
        (i) The employee and the individual become married; or
        (ii) The employee and individual are married and a child becomes a 
    dependent of the employee through birth, adoption or placement for 
    adoption.
        (5) Special enrollment of a dependent of a participant. An 
    individual is described in this paragraph (b)(5) if the individual is a 
    dependent of a participant and the individual becomes a dependent of 
    such participant through marriage, birth, or adoption or placement for 
    adoption.
        (6) Special enrollment of an employee who is eligible but not 
    enrolled and a new dependent. An employee who is eligible, but not 
    enrolled, in the plan, and an individual who is a dependent of the 
    employee, are described in this paragraph (b)(6) if the employee would 
    be a participant but for a prior election by the employee not to enroll 
    in the plan during a previous enrollment period, and the dependent 
    becomes a dependent of the employee through marriage, birth, or 
    adoption or placement for adoption.
        (7) Length of special enrollment period. The special enrollment 
    period under paragraph (b)(1) of this section is a period of not less 
    than 30 days and begins on the date of the marriage, birth, or adoption 
    or placement for adoption (except that such period does not begin 
    earlier than the date the plan makes dependent coverage generally 
    available).
        (8) Effective date of enrollment. Enrollment is effective--
        (i) In the case of marriage, not later than the first day of the 
    first calendar month beginning after the date the completed request for 
    enrollment is received by the plan;
        (ii) In the case of a dependent's birth, the date of such birth; 
    and
        (iii) In the case of a dependent's adoption or placement for 
    adoption, the date of such adoption or placement for adoption.
        (9) Example. The following example illustrates the requirements of 
    this paragraph (b):
    
        Example. (i) Employee A is hired on September 3, 1998 by 
    Employer X, which has a group health plan in which A can elect to 
    enroll either for employee-only coverage, for employee-plus-spouse 
    coverage, or for family coverage, effective on the first day of any 
    calendar quarter thereafter. A is married and has no children. A 
    does not elect to join Employer X's plan (for employee-only 
    coverage, employee-plus-spouse coverage, or family coverage) on 
    October 1, 1998 or January 1, 1999. On February 15, 1999, a child is 
    placed for adoption with A and A's spouse.
        (ii) In this Example, the conditions for special enrollment of 
    an employee with a new dependent under paragraph (b)(2) are 
    satisfied, the conditions for special enrollment of an employee and 
    a spouse with a new dependent under paragraph (b)(4) are satisfied, 
    and the conditions for special enrollment of an employee and a new 
    dependent under paragraph (b)(6) are satisfied. Accordingly, 
    Employer X's plan will satisfy this paragraph (b) if and only if it 
    allows A to elect, by filing the required forms by March 16, 1999, 
    to enroll in Employer X's plan either with employee-only coverage, 
    with employee-plus-spouse coverage, or with family coverage, 
    effective as of February 15, 1999.
    
        (c) Notice of enrollment rights. On or before the time an employee 
    is offered the opportunity to enroll in a group health plan, the plan 
    is required to provide the employee with a description of the plan's 
    special enrollment rules under this section. For this purpose, the plan 
    may use the following model description of the special enrollment rules 
    under this section:
    
        If you are declining enrollment for yourself or your dependents 
    (including your spouse) because of other health insurance coverage, 
    you may in the future be able to enroll yourself or your dependents 
    in this plan, provided that you request enrollment within 30 days 
    after your other coverage ends. In addition, if you have a new 
    dependent as a result of marriage, birth, adoption or placement for 
    adoption, you may be able to enroll yourself and your dependents, 
    provided that you request enrollment within 30 days after the 
    marriage, birth, adoption, or placement for adoption.
    
        (d) Special enrollment date definition. (1) General rule. A special 
    enrollment date for an individual means any date in paragraph (a)(7) or 
    paragraph (b)(8) of this section on which the individual has a right to 
    have enrollment in a group health plan become effective under this 
    section.
        (2) Examples. The following examples illustrate the requirements of 
    this paragraph (d):
    
        Example 1: (i) Employer Y maintains a group health plan that 
    allows employees to enroll in the plan either (a) effective on the 
    first day of employment by an election filed within three days 
    thereafter, (b) effective on any subsequent January 1 by an election 
    made during the preceding months of November or December, or (c) 
    effective as of any special enrollment date described in this 
    section. Employee B is hired by Employer Y on March 15, 1998 and 
    does not elect to enroll in Employer Y's plan until January 31, 1999 
    when B loses coverage under another plan. B elects to enroll in 
    Employer Y's plan effective on February 1, 1999 by filing the 
    completed request form by January 31, 1999, in accordance with the 
    special rule set forth in paragraph (a).
        (ii) In this Example, B has enrolled on a special enrollment 
    date because the enrollment is effective at a date described in 
    paragraph (a)(7).
        Example 2: (i) Same facts as Example 1, except that B's loss of 
    coverage under the other plan occurs on December 31, 1998 and B 
    elects to enroll in Employer Y's plan effective on January 1, 1999 
    by filing the completed request form by December 31, 1998, in 
    accordance with the special rule set forth in paragraph (a).
        (ii) In this Example, B has enrolled on a special enrollment 
    date because the enrollment is effective at a date described in 
    paragraph (a)(7) (even though this date is also a regular enrollment 
    date under the plan).
    
    
    Sec. 146.119  HMO affiliation period as alternative to preexisting 
    condition exclusion.
    
        (a) General. A group health plan offering health insurance coverage 
    through an HMO, or an HMO that offers health insurance coverage in 
    connection with a group health plan, may impose an affiliation period 
    only if each of the requirements in paragraph (b) of this section is 
    satisfied.
        (b) Requirements for affiliation period. (1) No preexisting 
    condition exclusion is imposed with respect to any coverage offered by 
    the HMO in connection with the particular group health plan.
        (2) No premium is charged to a participant or beneficiary for the 
    affiliation period.
        (3) The affiliation period for the HMO coverage is applied 
    uniformly without regard to any health status-related factors.
    
    [[Page 16969]]
    
        (4) The affiliation period does not exceed 2 months (or 3 months in 
    the case of a late enrollee).
        (5) The affiliation period begins on the enrollment date.
        (6) The affiliation period for enrollment in the HMO under a plan 
    runs concurrently with any waiting period.
        (c) Alternatives to affiliation period. An HMO may use alternative 
    methods in lieu of an affiliation period to address adverse selection, 
    as approved by the State insurance commissioner or other official 
    designated to regulate HMOs. Nothing in this section requires a State 
    to receive proposals for or approve alternatives to affiliation 
    periods.
    
    
    Sec. 146.121  Prohibiting discrimination against participants and 
    beneficiaries based on a health status-related factor.
    
        (a) In eligibility to enroll--(1) General. Subject to paragraph 
    (a)(2) of this section, a group health plan, and a health insurance 
    issuer offering group health insurance coverage in connection with a 
    group health plan, may not establish rules for eligibility (including 
    continued eligibility) of any individual to enroll under the terms of 
    the plan based on any of the following health status-related factors in 
    relation to the individual or a dependent of the individual:
        (i) Health status.
        (ii) Medical condition (including both physical and mental 
    illnesses), as defined in Sec. 146.102.
        (iii) Claims experience.
        (iv) Receipt of health care.
        (v) Medical history.
        (vi) Genetic information, as defined in Sec. 146.102.
        (vii) Evidence of insurability (including conditions arising out of 
    acts of domestic violence).
        (viii) Disability.
        (2) No application to benefits or exclusions. To the extent 
    consistent with section 2701 of the Act and Sec. 146.111, paragraph 
    (a)(1) of this section shall not be construed--
        (i) To require a group health plan, or a health insurance issuer 
    offering group health insurance coverage, to provide particular 
    benefits other than those provided under the terms of such plan or 
    coverage; or
        (ii) To prevent such a plan or issuer from establishing limitations 
    or restrictions on the amount, level, extent, or nature of the benefits 
    or coverage for similarly situated individuals enrolled in the plan or 
    coverage.
        (3) Construction. For purposes of paragraph (a)(1) of this section, 
    rules for eligibility to enroll include rules defining any applicable 
    waiting (or affiliation) periods for such enrollment and rules relating 
    to late and special enrollment.
        4. Example. The following example illustrates the requirements of 
    this paragraph (a):
    
        Example. (i) An employer sponsors a group health plan that is 
    available to all employees who enroll within the first 30 days of 
    their employment. However, individuals who do not enroll in the 
    first 30 days cannot enroll later unless they pass a physical 
    examination.
        (ii) In this Example, the plan discriminates on the basis of one 
    or more health status-related factors.
    
        (b) In premiums or contributions--(1) General. A group health plan, 
    and a health insurance issuer offering health insurance coverage in 
    connection with a group health plan, may not require an individual (as 
    a condition of enrollment or continued enrollment under the plan) to 
    pay a premium or contribution that is greater than the premium or 
    contribution for a similarly situated individual enrolled in the plan 
    based on any health status-related factor, in relation to the 
    individual or a dependent of the individual.
        (2) Construction. Nothing in paragraph (b)(1) of this section can 
    be construed--
        (i) To restrict the amount that an employer may be charged by an 
    issuer for coverage under a group health plan; or
        (ii) To prevent a group health plan, and a health insurance issuer 
    offering group health insurance coverage, from establishing premium 
    discounts or rebates or modifying otherwise applicable copayments or 
    deductibles in return for adherence to a bona fide wellness program. 
    For purposes of this section, a bona fide wellness program is a program 
    of health promotion and disease prevention.
        (3) Example. The following example illustrates the requirements of 
    this paragraph (b):
    
        Example. (i) Plan X offers a premium discount to participants 
    who adhere to a cholesterol-reduction wellness program. Enrollees 
    are expected to keep a diary of their food intake over 6 weeks. They 
    periodically submit the diary to the plan physician who responds 
    with suggested diet modifications. Enrollees are to modify their 
    diets in accordance with the physician's recommendations. At the end 
    of the 6 weeks, enrollees are given a cholesterol test and those who 
    achieve a count under 200 receive a premium discount.
        (ii) In this Example, because enrollees who otherwise comply 
    with the program may be unable to achieve a cholesterol count under 
    200 due to a health status-related factor, this is not a bona fide 
    wellness program and such discounts would discriminate impermissibly 
    based on one or more health status-related factors. However, if, 
    instead, individuals covered by the plan were entitled to receive 
    the discount for complying with the diary and dietary requirements 
    and were not required to pass a cholesterol test, the program would 
    be a bona fide wellness program.
    
    
    Sec. 146.125  Effective dates.
    
        (a) General effective dates--(1) Non-collectively-bargained plans. 
    Except as otherwise provided in this section, part A of title XXVII of 
    the PHS Act and this part applies with respect to group health plans, 
    including health insurance issuers offering health insurance coverage 
    in connection with group health plans, for plan years beginning after 
    June 30, 1997.
        (2) Collectively bargained plans. Except as otherwise provided in 
    this section (other than paragraph (a)(1)), in the case of a group 
    health plan maintained under one or more collective bargaining 
    agreements between employee representatives and one or more employers 
    ratified before August 21, 1996, part A of title XXVII of the PHS Act 
    and this part does not apply to plan years beginning before the later 
    of July 1, 1997, or the date on which the last of the collective 
    bargaining agreements relating to the plan terminates (determined 
    without regard to any extension thereof agreed to after August 21, 
    1996). For these purposes, any plan amendment made under a collective 
    bargaining agreement relating to the plan, that amends the plan solely 
    to conform to any requirement of such part, is not treated as a 
    termination of the collective bargaining agreement.
        (3) Preexisting condition exclusion periods for current employees. 
    (i) General rule. Any preexisting condition exclusion period permitted 
    under Sec. 146.111 is measured from the individual's enrollment date in 
    the plan. This exclusion period, as limited under Sec. 146.111, may be 
    completed before the effective date of the Health Insurance Portability 
    and Accountability Act of 1996 (HIPAA) for his or her plan. Therefore, 
    on the date the individual's plan becomes subject to part A of title 
    XXVII of the PHS Act, no preexisting condition exclusion may be imposed 
    with respect to an individual beyond the limitation in Sec. 146.111. 
    For an individual who has not completed the permitted exclusion period 
    under HIPAA, upon the effective date for his or her plan, the 
    individual may use credible coverage that the person had as of the 
    enrollment date to reduce the remaining preexisting condition exclusion 
    period applicable to the individual.
    
    [[Page 16970]]
    
        (ii) Examples. The following examples illustrate the requirements 
    of this paragraph (a)(3):
    
        Example 1: (i) Individual A has been working for Employer X and 
    has been covered under Employer X's plan since March 1, 1997. Under 
    Employer X's plan, as in effect before January 1, 1998, there is no 
    coverage for any preexisting condition. Employer X's plan year 
    begins on January 1, 1998. A's enrollment date in the plan is March 
    1, 1997, and A has no credible coverage before this date.
        (ii) In this Example, Employer X may continue to impose the 
    preexisting conditions exclusion under the plan through February 28, 
    1998 (the end of the 12-month period using anniversary dates).
        Example 2: (i) Same facts as in Example 1, except that A's 
    enrollment date was August 1, 1996, instead of March 1, 1997.
        (ii) In this Example, on January 1, 1998, Employer X's plan may 
    no longer exclude treatment for any preexisting condition that A may 
    have, however, because Employer X's plan is not subject to HIPAA 
    until January 1, 1998, A is not entitled to claim reimbursement for 
    expenses under the plan for treatments for any preexisting condition 
    received before January 1, 1998.
    
        (b) Effective date for certification requirement--(1) General. 
    Subject to the transitional rule in Sec. 146.115(a)(5)(iii), the 
    certification rules of Sec. 146.115 apply to events occurring on or 
    after July 1, 1996.
        (2) Period covered by certificate. A certificate is not required to 
    reflect coverage before July 1, 1996.
        (3) No certificate before June 1, 1997. Notwithstanding any other 
    provision of this part, in no case is a certificate required to be 
    provided before June 1, 1997.
        (c) Limitation on actions. No enforcement action is taken, under, 
    against a group health plan or health insurance issuer with respect to 
    a violation of a requirement imposed by part A of title XXVII of the 
    PHS Act before January 1, 1998, if the plan or issuer has sought to 
    comply in good faith with such requirements. Compliance with this part 
    is deemed to be good faith compliance with the requirements of part A 
    of title XXVII of the PHS Act.
        (d) Transition rules for counting creditable coverage. An 
    individual who seeks to establish creditable coverage for periods 
    before July 1, 1996 is entitled to establish such coverage through the 
    presentation of documents or other means in accordance with the 
    provisions of Sec. 146.115(c). For coverage relating to an event 
    occurring before July 1, 1996, a group health plan and a health 
    insurance issuer is not subject to any penalty or enforcement action 
    with respect to the plan's or issuer's counting (or not counting) such 
    coverage if the plan or issuer has sought to comply in good faith with 
    the applicable requirements under Sec. 146.115(c).
        (e) Transition rules for certification of creditable coverage--(1) 
    Certificates only upon request. For events occurring on or after July 
    1, 1996 but before October 1, 1996, a certificate is required to be 
    provided only upon a written request by or on behalf of the individual 
    to whom the certificate applies.
        (2) Certificates before June 1, 1997. For events occurring on or 
    after October 1, 1996 and before June 1, 1997, a certificate must be 
    furnished no later than June 1, 1997, or any later date permitted under 
    Sec. 146.115(a)(2) (ii) and (iii).
        (3) Optional notice--(i) General. This paragraph (e)(3) applies 
    with respect to events described in Sec. 146.115(a)(5)(ii), that occur 
    on or after October 1, 1996 but before June 1, 1997. A group health 
    plan or health insurance issuer offering group health coverage is 
    deemed to satisfy Secs. 146.115 (a)(2) and (a)(3) if a notice is 
    provided in accordance with the provisions of paragraphs (e)(3)(i) 
    through (e)(3)(iv) of this section.
        (ii) Time of notice. The notice must be provided no later than June 
    1, 1997.
        (iii) Form and content of notice. A notice provided under this 
    paragraph (e)(3) must be in writing and must include information 
    substantially similar to the information included in a model notice 
    authorized by HCFA. Copies of the model notice are available at the 
    following website--www.hcfa.gov (or call (410) 786-1565).
        (iv) Providing certificate after request. If an individual requests 
    a certificate following receipt of the notice, the certificate must be 
    provided at the time of the request as set forth in 
    Sec. 146.115(a)(5)(iii).
        (v) Other certification rules apply. The rules set forth in 
    Sec. 146.115(a)(4)(i) (method of delivery) and (a)(1) (entities 
    required to provide a certificate) apply with respect to the provision 
    of the notice.
    
    Subpart C--[Reserved]
    
    Subpart D--Preemption and Special Rules
    
    
    Sec. 146.143  Preemption; State flexibility; construction.
    
        (a) Continued applicability of State law with respect to health 
    insurance issuers. Subject to paragraph (b) of this section and except 
    as provided in paragraph (c) of this section, part A of title XXVII of 
    the PHS Act is not to be construed to supersede any provision of State 
    law which establishes, implements, or continues in effect any standard 
    or requirement solely relating to health insurance issuers in 
    connection with group health insurance coverage except to the extent 
    that such standard or requirement prevents the application of a 
    requirement of part A of title XXVII of the PHS Act.
        (b) Continued preemption with respect to group health plans. 
    Nothing in part A of title XXVII of the PHS Act affects or modifies the 
    provisions of section 514 of ERISA with respect to group health plans.
        (c) Special rules--(1) General. Subject to paragraph (c)(2) of this 
    section, the provisions of part A of title XXVII of the PHS Act 
    relating to health insurance coverage offered by a health insurance 
    issuer supersede any provision of State law which establishes, 
    implements, or continues in effect a standard or requirement applicable 
    to imposition of a preexisting condition exclusion specifically 
    governed by section 2701 of the PHS Act, which differs from the 
    standards or requirements specified in such section.
        (2) Exceptions. Only in relation to health insurance coverage 
    offered by a health insurance issuer, the provisions of this part do 
    not supersede any provision of State law to the extent that such 
    provision--
        (i) Shortens the period of time from the ``6-month period'' 
    described in section 2701(a)(1) of the PHS Act and 
    Sec. 146.111(a)(1)(i) (for purposes of identifying a preexisting 
    condition);
        (ii) Shortens the period of time from the ``12 months'' and ``18 
    months'' described in section 2701(a)(2) of the PHS Act and 
    Sec. 146.111(a)(1)(ii) (for purposes of applying a preexisting 
    condition exclusion period);
        (iii) Provides for a greater number of days than the ``63-day 
    period'' described in sections 2701 (c)(2)(A) and (d)(4)(A) of the PHS 
    Act and Secs. 146.111(a)(1)(iii) and 146.113 (for purposes of applying 
    the break in coverage rules);
        (iv) Provides for a greater number of days than the ``30-day 
    period'' described in sections 2701 (b)(2) and (d)(1) of the PHS Act 
    and Sec. 146.111(b) (for purposes of the enrollment period and 
    preexisting condition exclusion periods for certain newborns and 
    children that are adopted or placed for adoption);
        (v) Prohibits the imposition of any preexisting condition exclusion 
    in cases not described in section 2701(d) of the PHS Act or expands the 
    exceptions described in that section;
        (vi) Requires special enrollment periods in addition to those 
    required under section 2701(f) of the PHS Act; or
        (vii) Reduces the maximum period permitted in an affiliation period 
    under section 701(g)(1)(B).
    
    [[Page 16971]]
    
        (d) Definitions--(1) State law. For purposes of this section the 
    term ``State law'' includes all laws, decisions, rules, regulations, or 
    other State action having the effect of law, of any State. A law of the 
    United States applicable only to the District of Columbia is treated as 
    a State law rather than a law of the United States.
        (2) State. For purposes of this section the term ``State'' includes 
    a State, the Northern Mariana Islands, any political subdivisions of a 
    State or such Islands, or any agency or instrumentality of either.
    
    
    Sec. 146.145  Special rules relating to group health plans.
    
        (a) General exception for certain small group health plans. The 
    requirements of this part do not apply to any group health plan (and 
    group health insurance coverage offered in connection with a group 
    health plan) for any plan year if, on the first day of the plan year, 
    the plan has fewer than 2 participants who are current employees.
        (b) Excepted benefits--(1) General. The requirements of subpart B 
    of this part do not apply to any group health plan (or any group health 
    insurance coverage offered in connection with a group health plan) in 
    relation to its provision of the benefits described in paragraph 
    (b)(2), (3), (4), or (5) of this section (or any combination of these 
    benefits).
        (2) Benefits excepted in all circumstances. The following benefits 
    are excepted in all circumstances:
        (i) Coverage only for accident (including accidental death and 
    dismemberment).
        (ii) Disability income insurance.
        (iii) Liability insurance, including general liability insurance 
    and automobile liability insurance.
        (iv) Coverage issued as a supplement to liability insurance.
        (v) Workers' compensation or similar insurance.
        (vi) Automobile medical payment insurance.
        (vii) Credit-only insurance (for example, mortgage insurance).
        (viii) Coverage for on-site medical clinics.
        (3) Limited excepted benefits--(1) General. Limited-scope dental 
    benefits, limited-scope vision benefits, or long-term care benefits are 
    excepted if they are provided under a separate policy, certificate, or 
    contract of insurance, or are otherwise not an integral part of the 
    plan, as defined in paragraph (b)(3)(ii) of this section.
        (ii) Integral. For purposes of paragraph (b)(3)(i) of this section, 
    benefits are deemed to be an integral part of a plan unless a 
    participant has the right to elect not to receive coverage for the 
    benefits and, if the participant elects to receive coverage for the 
    benefits, the participant pays an additional premium or contribution 
    for that coverage.
        (iii) Limited scope. Limited scope dental or vision benefits are 
    dental or vision benefits that are sold under a separate policy or 
    rider and that are limited in scope to a narrow range or type of 
    benefits that are generally excluded from hospital/medical/surgical 
    benefits packages.
        (iv) Long-term care. Long-term care benefits are benefits that are 
    either--
        (A) Subject to State long-term care insurance laws;
        (B) For qualified long-term care insurance services, as defined in 
    section 7702B(c)(1) of the Internal Revenue Code, or provided under a 
    qualified long-term care insurance contract, as defined in section 
    7702B(b) of the Internal Revenue Code; or
        (C) based on cognitive impairment or a loss of functional capacity 
    that is expected to be chronic.
        (4) Noncoordinated benefits--(i) Excepted benefits that are not 
    coordinated. Coverage for only a specified disease or illness (for 
    example, cancer-only policies) or hospital indemnity or other fixed 
    dollar indemnity insurance (for example, $100/day) is expected only if 
    it meets each of the conditions specified in paragraph (b)(4)(ii) of 
    this section.
        (ii) Conditions. Benefits are described in paragraph (b)(4)(i) of 
    this section only if--
        (A) The benefits are provided under a separate policy, certificate, 
    or contract of insurance;
        (B) There is no coordination between the provision of the benefits 
    and an exclusion of benefits under any group health plan maintained by 
    the same plan sponsor; and
        (C) The benefits are paid with respect to an event without regard 
    to whether benefits are provided with respect to the event under any 
    group health plan maintained by the same plan sponsor.
        (5) Supplemental benefits. The following benefits are excepted only 
    if they are provided under a separate policy, certificate, or contract 
    of insurance:
        (i) Medicare supplemental health insurance (as defined under 
    section 1882(g)(1) of the Social Security Act; also known as Medigap or 
    MedSupp insurance),
        (ii) Coverage supplemental to the coverage provided under Chapter 
    55, Title 10 of the United States Code (also known as CHAMPUS 
    supplemental programs), and
        (iii) Similar supplemental coverage provided to coverage under a 
    group health plan.
    
    Subpart E--Provisions Applicable to Only Health Insurance Issuers
    
    
    Sec. 146.150  Guaranteed availability of coverage for employers in the 
    small group market.
    
        (a) Issuance of coverage in the small group market. Subject to 
    paragraphs (c) through (f) of this section, each health insurance 
    issuer that offers health insurance coverage in the small group market 
    in a State must--
        (1) Offer, to any small employer in the State, all products that 
    are approved for sale in the small group market and that the issuer is 
    actively marketing, and must accept any employer that applies for any 
    of those products; and
        (2) Accept for enrollment under the coverage every eligible 
    individual (as defined in paragraph (b) of this section) who applies 
    for enrollment during the period in which the individual first becomes 
    eligible to enroll under the terms of the group health plan, or during 
    a special enrollment period, and may not impose any restriction on an 
    eligible individual, which is inconsistent with the nondiscrimination 
    provisions of Sec. 146.121 on an eligible individual being a 
    participant or beneficiary.
        (b) Eligible individual defined. For purposes of this section, the 
    term ``eligible individual'' means an individual who is eligible--
        (1) To enroll in group health insurance coverage offered to a group 
    health plan maintained by a small employer, in accordance with the 
    terms of the group health plan;
        (2) For coverage under the rules of the health insurance issuer 
    which are uniformly applicable in the State to small employers in the 
    small group market, and
        (3) For coverage in accordance with all applicable State laws 
    governing the issuer and the small group market.
        (c) Special rules for network plans. (1) In the case of a health 
    insurance issuer that offers health insurance coverage in the small 
    group market through a network plan, the issuer may--
        (i) Limit the employers that may apply for the coverage to those 
    with eligible individuals who live, work, or reside in the service area 
    for the network plan; and
        (ii) Within the service area of the plan, deny coverage to 
    employers if the issuer has demonstrated to the applicable State 
    authority (if required by the State authority) that--
    
    [[Page 16972]]
    
        (A) It will not have the capacity to deliver services adequately to 
    enrollees of any additional groups because of its obligations to 
    existing group contract holders and enrollees; and
        (B) It is applying this paragraph (c)(1) uniformly to all employers 
    without regard to the claims experience of those employers and their 
    employees (and their dependents) or any health status-related factor 
    relating to those employees and dependents.
        (2) An issuer that denies health insurance coverage to an employer 
    in any service area in accordance with paragraph (c)(1)(ii) of this 
    section, may not offer coverage in the small group market within the 
    service area to any employer for a period of 180 days after the date 
    the coverage is denied. This paragraph (c)(2) does not limit the 
    issuer's ability to renew coverage already in force or relieve the 
    issuer of the responsibility to renew that coverage.
        (3) Coverage offered within a service area after the 180-day period 
    specified in paragraph (c)(2) of this section is subject to the 
    requirements of this section.
        (d) Application of financial capacity limits. (1) A health 
    insurance issuer may deny health insurance coverage in the small group 
    market if the issuer has demonstrated to the applicable State authority 
    (if required by the State authority) that it--
        (i) Does not have the financial reserves necessary to underwrite 
    additional coverage; and
        (ii) Is applying this paragraph (d)(1) uniformly to all employers 
    in the small group market in the State consistent with applicable State 
    law and without regard to the claims experience of those employers and 
    their employees (and their dependents) or any health status-related 
    factor relating to those employees and dependents.
        (2) An issuer that denies group health insurance coverage to any 
    small employer in a State in accordance with paragraph (d)(1) of this 
    section may not offer coverage in connection with group health plans in 
    the small group market in the State for a period of 180 days after the 
    later of the date--
        (i) The coverage is denied; or
        (ii) The issuer demonstrates to the applicable State authority, if 
    required under applicable State law, that the issuer has sufficient 
    financial reserves to under write additional coverage.
        (3) Paragraph (d)(2) of this section does not limit the issuer's 
    ability to renew coverage already in force or relieve the issuer of the 
    responsibility to renew that coverage.
        (4) Coverage offered after the 180-day period specified in 
    paragraph (d)(2) of this section, is subject to the requirements of 
    this section.
        (5) An applicable State authority may provide for the application 
    of this paragraph (d) of this section on a service-area-specific basis.
        (e) Exception to requirement for failure to meet certain minimum 
    participation or contribution rules.
        (1) Paragraph (a) of this section does not preclude a health 
    insurance issuer from establishing employer contribution rules or group 
    participation rules for the offering of health insurance coverage in 
    connection with a group health plan in the small group market, as 
    allowed under applicable State law.
        (2) For purposes of paragraph (e)(1) of this section--
        (i) The term ``employer contribution rule'' means a requirement 
    relating to the minimum level or amount of employer contribution toward 
    the premium for enrollment of participants and beneficiaries; and
        (ii) The term ``group participation rule'' means a requirement 
    relating to the minimum number of participants or beneficiaries that 
    must be enrolled in relation to a specified percentage or number of 
    eligible individuals or employees of an employer.
        (f) Exception for coverage offered only to bona fide association 
    members. Paragraph (a) of this section does not apply to health 
    insurance coverage offered by a health insurance issuer if that 
    coverage is made available in the small group market only through one 
    or more bona fide associations (as defined in 45 CFR 144.103).
    
    
    Sec. 146.152  Guaranteed renewability of coverage for employers in the 
    group market.
    
        (a) General rule. Subject to paragraphs (b) through (d) of this 
    section, a health insurance issuer offering health insurance coverage 
    in the small or large group market is required to renew or continue in 
    force the coverage at the option of the plan sponsor.
        (b) Exceptions. An issuer may nonrenew or discontinue group health 
    insurance coverage offered in the small or large group market based 
    only on one or more of the following:
        (1) Nonpayment of premiums. The plan sponsor as failed to pay 
    premiums or contributions in accordance with the terms of the health 
    insurance coverage, including any timeliness requirements.
        (2) Fraud. The plan sponsor has performed an act or practice that 
    constitutes fraud or made an intentional misrepresentation of material 
    fact in connection with the coverage.
        (3) Violation of participation or contribution rules. The plan 
    sponsor has failed to comply with a material plan provision relating to 
    any employer contribution or group participation rules permitted under 
    Sec. 146.150(e) in the case of the small group market or under 
    applicable State law in the case of the large group market.
        (4) Termination of plan. The issuer is ceasing to offer coverage in 
    the market in accordance with paragraphs (c) and (d) of this section 
    and applicable State law.
        (5) Enrollees' movement outside service area. For network plans, 
    there is no longer any enrollee under the group health plan who lives, 
    resides, or works in the service area of the issuer (or in the area for 
    which the issuer is authorized to do business); and in the case of the 
    small group market, the issuer applies the same criteria it would apply 
    in denying enrollment in the plan under Sec. 146.150(c).
        (6) Association membership ceases. For coverage made available in 
    the small or large group market only through one or more bona fide 
    associations, if the employer's membership in the association ceases, 
    but only if the coverage is terminated uniformly without regard to any 
    health status-related factor relating to any covered individual.
        (c) Discontinuing a particular product. In any case in which an 
    issuer decides to discontinue offering a particular product offered in 
    the small or large group market, that product may be discontinued by 
    the issuer in accordance with applicable State law in the particular 
    market only if--
        (1) The issuer provides notice in writing to each plan sponsor 
    provided that particular product in that market (and to all 
    participants and beneficiaries covered under such coverage) of the 
    discontinuation at least 90 days before the date the coverage will be 
    discontinued;
        (2) The issuer offers to each plan sponsor provided that particular 
    product the option, on a guaranteed issue basis, to purchase all (or, 
    in the case of the large group market, any) other health insurance 
    coverage currently being offered by the issuer to a group health plan 
    in that market; and
        (3) In exercising the option to discontinue that product and in 
    offering the option of coverage under paragraph (c)(2) of this section, 
    the issuer acts uniformly without regard to the claims experience of 
    those sponsors or any health status-related factor relating to any 
    participants or beneficiaries covered or new participants or 
    beneficiaries who may become eligible for such coverage.
    
    [[Page 16973]]
    
        (d) Discontinuing all coverage. An issuer may elect to discontinue 
    offering all health insurance coverage in the small or large group 
    market or both markets in a State in accordance with applicable State 
    law only if--
        (1) The issuer provides notice in writing to the applicable State 
    authority and to each plan sponsor (and all participants and 
    beneficiaries covered under the coverage) of the discontinuation at 
    least 180 days prior to the date the coverage will be discontinued; and
        (2) All health insurance policies issued or delivered for issuance 
    in the State in the market (or markets) are discontinued and not 
    renewed.
        (e) Prohibition on market reentry. An issuer who elects to 
    discontinue offering all health insurance coverage in a market (or 
    markets) in a State as described in paragraph (d) of this section may 
    not issue coverage in the market (or markets) and State involved during 
    the 5-year period beginning on the date of discontinuation of the last 
    coverage not renewed.
        (f) Exception for uniform modification of coverage. Only at the 
    time of coverage renewal may issuers modify the health insurance 
    coverage for a product offered to a group health plan in the--
        (1) Large group market; and
        (2) Small group market if, for coverage available in this market 
    (other than only through one or more bona fide associations), the 
    modification is consistent with State law and is effective uniformly 
    among group health plans with that product.
        (g) Application to coverage offered only through associations. In 
    the case of health insurance coverage that is made available by a 
    health insurance issuer in the small or large group market to employers 
    only through one or more associations, the reference to ``plan 
    sponsor'' is deemed, with respect to coverage provided to an employer 
    member of the association, to include a reference to such employer.
    
    
    Sec. 146.160  Disclosure of information.
    
        (a) General rule. In connection with the offering of any health 
    insurance coverage to a small employer, a health insurance issuer is 
    required to--
        (1) Make a reasonable disclosure to the employer, as part of its 
    solicitation and sales materials, of the availability of information 
    described in paragraph (b) of this section; and
        (2) Upon request of the employer, provide that information to the 
    employer.
        (b) Information described. Subject to paragraph (d) of this 
    section, information that must be provided under paragraph (a)(2) of 
    this section is information concerning the following:
        (1) Provisions of coverage relating to the following:
        (i) The issuer's right to change premium rates and the factors that 
    may affect changes in premium rates.
        (ii) Renewability of coverage.
        (iii) Any preexisting condition exclusion, including use of the 
    alternative method of counting creditable coverage.
        (iv) Any affiliation periods applied by HMOs.
        (v) The geographic areas served by HMOs.
        (2) The benefits and premiums available under all health insurance 
    coverage for which the employer is qualified, under applicable State 
    law. See Sec. 146.150(b) through (f) for allowable limitations on 
    product availability.
        (c) Form of information. The information must be described in 
    language that is understandable by the average small employer, with a 
    level of detail that is sufficient to reasonably inform small employers 
    of their rights and obligations under the health insurance coverage. 
    This requirement is satisfied if the issuer provides each of the 
    following with respect to each product offered:
        (1) An outline of coverage. For purposes of this section, outline 
    of coverage means a description of benefits in summary form.
        (2) The rate or rating schedule that applies to the product (with 
    and without the preexisting condition exclusion or affiliation period).
        (3) The minimum employer contribution and group participation rules 
    that apply to any particular type of coverage.
        (4) In the case of a network plan, a map or listing of counties 
    served.
        (5) Any other information required by the State.
        (d) Exception. An issuer is not required to disclose any 
    information that is proprietary and trade secret information under 
    applicable law.
    
    Subpart F--Exclusion of Plans and Enforcement
    
    
    Sec. 146.180  Treatment on non-Federal governmental plans.
    
        The plan sponsor of a non-Federal governmental plan may elect to be 
    exempted from any or all of the requirements identified in paragraph 
    (a) of this section with respect to any portion of its plan that is not 
    provided through health insurance coverage, if the election complies 
    with the requirements of paragraphs (b) and (c) of this section. The 
    election remains in effect for the period described in paragraph (d) of 
    this section.
        (a) Exemption from requirements. The election described in this 
    paragraph (a) exempts a non-Federal governmental plan from the 
    following requirements:
        (1) Limitations on preexisting condition exclusion periods 
    (Sec. 146.111).
        (2) Special enrollment periods for individuals (and dependents) 
    losing other coverage (Sec. 146.117).
        (3) Prohibitions against discriminating against individual 
    participants and beneficiaries based on health status (Sec. 146.121).
        (4) Standards relating to benefits for mothers and newborns 
    (section 2704 of the PHS Act).
        (5) Parity in the application of certain limits to mental health 
    benefits (section 2705 of the PHS Act).
        (b) Form and manner of election. (1) The election must be in 
    writing.
        (2) The election document must include as an attachment a copy of 
    the notice described in paragraphs (f) and (g) of this section.
        (3) The election document must state the name of the plan and the 
    name and address of the plan administrator.
        (4) The election document must either state that the plan does not 
    include health insurance coverage, or identify which portion of the 
    plan is not funded through insurance.
        (5) The election must be made in conformity with all the plan 
    sponsor's rules, including any public hearing, if required, and the 
    election document must certify that the person signing the election 
    document, including if applicable a third party plan administrator, is 
    legally authorized to do so by the plan sponsor.
        (6) The election document must be signed by the person described in 
    paragraph (b)(5) of this section.
        (c) Timing of election. (1) For plans not subject to collective 
    bargaining agreements, the election must be received by HCFA by the day 
    preceding the beginning date of the plan year.
        (2) For plans provided under a collective bargaining agreement, the 
    election must be received by HCFA no later than 30 days after--
        (i) The date of the agreement between the governmental entity and 
    union officials; or
        (ii) If applicable, ratification of the agreement.
        (3) HCFA may extend the deadlines specified under paragraphs (c)(1) 
    and (c)(2) of this section for good cause.
        (4) If the plan sponsor fails to file a timely election in 
    accordance with paragraphs (c)(1) through (c)(3) of this section, the 
    plan is subject to the
    
    [[Page 16974]]
    
    requirements described in paragraph (a) for the entire plan year, or, 
    in the case of a plan provided under a collective bargaining agreement, 
    for the term of the agreement.
        (d) Period of election. An election under paragraph (a) of this 
    section applies--
        (1) For a single specified plan year; or
        (2) In the case of a plan provided under a collective bargaining 
    agreement, for the term of the agreement. (For purposes of this 
    section, if a collective bargaining agreement expires during the 
    bargaining process for a new agreement, and the parties agree that the 
    prior bargaining agreement continues in effect until the new agreement 
    takes effect, the ``term of the agreement'' is deemed to continue until 
    the new agreement takes effect.)
        (e) Subsequent elections. An election under this section may be 
    extended through subsequent elections.
        (f) Notice to participants. (1) A plan that makes the election 
    described in this section notifies the participant of the election, and 
    explains the consequences of the election. This notice must be 
    provided--
        (i) to each participant at the time of enrollment under the plan; 
    and
        (ii) To all participants on an annual basis.
        (2) The notice shall be in writing, and must include the 
    information specified in paragraph (g) of this section.
        (3) The notice shall be provided to each participant individually.
        (4) Subject to paragraph (g) of this section, the requirements of 
    paragraphs (f)(1) through (f)(3) of this section are considered to have 
    been met if the notice is prominently printed in the summary plan 
    document, or equivalent document, and each participant receives a copy 
    of that document at the time of enrollment and annually thereafter.
        (g) Notice content. The notice must contain at least the following 
    information:
        (1) A statement that, in general, Federal law imposes upon group 
    health plans the requirements described in paragraph (a) of this 
    section (which must be individually described in the notice).
        (2) A statement that Federal law gives the plan sponsor of a non-
    Federal governmental plan the right to exempt the plan in whole or in 
    part from the requirements described in paragraph (a) of this section, 
    and that the plan sponsor has elected to do so.
        (3) A statement identifying which parts of the plan are subject to 
    the election, and each of the requirements of paragraph (a) of this 
    section from which the plan sponsor has elected to be exempted.
        (4) If the plan chooses to provide any of the protections of 
    paragraph (a) of this section voluntarily, or is required to under 
    State law, a statement identifying which protections apply.
        (h) Certification and disclosure of creditable coverage. 
    Notwithstanding an election under this section, a non-Federal 
    governmental plan must provide for certification and disclosure of 
    creditable coverage under the plan with respect to participants and 
    their dependents in accordance with Sec. 146.115.
        (i) Effect of failure to comply with election requirements. (1) 
    Subject to paragraph (i)(2) of this section, a plan's failure to comply 
    with the requirements of paragraphs (f) through (h) of this section 
    invalidates an election made under this section.
        (2) Upon a finding by HCFA that a non-Federal governmental plan has 
    failed to comply with the requirements of paragraphs (f) through (h), 
    and has failed to correct the noncompliance within 30 days (as provided 
    in Sec. 146.184(d) (7)(iii)(B)), HCFA notifies the plan that its 
    election has been invalidated and that it is subject to the 
    requirements of this part.
        (3) A non-Federal governmental plan described in paragraph (i)(2) 
    of this section that fails to comply with the requirements of this part 
    is subject to Federal enforcement by HCFA under Sec. 146.184, including 
    appropriate civil money penalties.
    
    
    Sec. 146.184  Enforcement.
    
        (a) Enforcement with respect to group health plans--(1) Scope. In 
    general, the requirements of the Health Insurance Portability and 
    Accountability Act that apply to group health plans are contained in 
    part 7 of subtitle B of title I of ERISA, and in subtitle K of the 
    Internal Revenue Code. They are enforced by the Secretary of Labor 
    under part 5 of subtitle B of title I of ERISA, and the Secretary of 
    the Treasury under 26 U.S.C. 4980D. However, the provisions that apply 
    to group health plans that are non-Federal governmental plans are 
    contained in title XXVII of the PHS Act, and enforced by HCFA. The 
    provisions of title XXVII that apply to health insurance issuers that 
    offer coverage in connection with any group health plan are enforced in 
    the first instance by the States. If HCFA determines under paragraph 
    (b) of this section that a State is not substantially enforcing the 
    provisions, HCFA enforces them under paragraph (d) of this section.
        (2) Non-Federal governmental plans. Requirements of this part that 
    apply to group health plans that are non-Federal governmental plans 
    (sponsored by a State or local governmental entity) are enforced by 
    HCFA, as provided in paragraph (d) of this section.
        (b) Enforcement with respect to health insurance issuers--(1) 
    General rule--enforcement by State. Except as provided in paragraph 
    (b)(2) of this section, each State enforces the requirements of this 
    part with respect to health insurance issuers that issue, sell, renew 
    or offer health insurance coverage in the small or large group markets 
    in the State.
        (2) Enforcement by HCFA. HCFA enforces the provisions of this part 
    with respect to health insurance issuers, using the procedures 
    described in paragraph (d) of this section, only in the following 
    circumstances:
        (i) State election. If the State chooses not to enforce the Federal 
    requirements.
        (ii) State failure to enforce. If HCFA makes a determination under 
    paragraph (c) of this section that a State has failed to substantially 
    enforce one or more provisions of this part.
        (c) Determination by Administrator. if HCFA receives information, 
    through a complaint or any other means, that raises a question whether 
    a State is substantially enforcing one or more provisions of this part, 
    HCFA follows the procedures set forth in this section.
        (1) Verification of exhaustion. HCFA makes a threshold 
    determination of whether the individuals affected by the alleged 
    failure to enforce have made a reasonable effort to exhaust any State 
    remedies. This may involve informal contact with State officials about 
    the questions raised.
        (2) Notice to the State. If HCFA is satisfied that there is a 
    reasonable question whether there has been a failure to substantially 
    enforce, HCFA provides notice as specified in paragraph (c)(3) of this 
    section, to the following State officials:
        (i) The Governor or chief executive officer of the State.
        (ii) The insurance commissioner or chief insurance regulatory 
    official.
        (iii) The official responsible for regulating HMOs, if different 
    than paragraph (c)(2)(ii) of this section, but only if the alleged 
    failure involves HMOs.
        (3) Form and content of notice. The notice described in paragraph 
    (c)(2) is in writing, and does the following:
        (i) Identifies the provision or provisions of the statute and 
    regulations that have allegedly been violated;
        (ii) Describes the facts of the specific violations.
    
    [[Page 16975]]
    
        (iii) Explains that the consequence of a failure to substantially 
    enforce any provisions(s) is that HCFA enforces the provision(s) in 
    accordance with paragraph (d) of this section.
        (iv) Advises the State that it has 45 days to respond to the 
    notice, unless the time is extended as described in paragraph (c)(3) of 
    this section, and that the response should include any information that 
    the State wishes HCFA to consider in making the preliminary 
    determination described in paragraph (c)(5) of this section.
        (4) Good cause. The time for responding can be extended for good 
    cause. Examples of good cause include an agreement between HCFA and the 
    State that there should be a public hearing on the State's enforcement, 
    or evidence that the State is undertaking expedited enforcement 
    activities.
        (5) Preliminary determination. If at the end of the 45-day period, 
    and any extension, the State has not established to HCFA's satisfaction 
    that it is substantially enforcing the provision or provisions 
    described in the notice, HCFA takes the following actions:
        (i) Consults with the officials described in paragraph (c)(1) of 
    this section.
        (ii) Notifies the State of HCFA's preliminary determination that 
    the State has failed to enforce the provisions, and that the failure is 
    continuing.
        (iii) Permits the State a reasonable opportunity to show evidence 
    of substantial enforcement.
        (6) Final determination. If, after providing notice and the 
    opportunity to enforce under paragraph (c)(5) of this section, HCFA 
    finds that the failure to enforce has not been corrected, HCFA sends 
    the State a written notice of that final determination. The notice--
        (i) Identifies the provisions with respect to which HCFA is taking 
    over enforcement;
        (ii) States the effective date of HCFA's enforcement;
        (iii) Informs the State of the mechanism for establishing in the 
    future that it has corrected the failure, and has begun enforcement. 
    This mechanism will include transition procedures for ending HCFA's 
    enforcement.
        (d) Civil money penalties--(1) General rule. If any health 
    insurance issuer that is subject to HCFA's enforcement authority under 
    paragraph (b)(2) of this section, or any non-Federal governmental plan 
    (or employer that sponsors a non-Federal governmental plan) that is 
    subject to HCFA's enforcement authority under paragraph (a)(2) of this 
    section, fails to comply with any applicable requirement of this part, 
    if may be subject to a civil money penalty as described in this 
    paragraph (d).
        (2) Complaint. Any person who is entitled to any right under this 
    part, and who believes that the right is being denied as a result of 
    any failure described in paragraph (d)(1) of this section, may file a 
    complaint with HCFA. Based on the complaint, HCFA identifies which 
    entities are potentially responsible for the violation, in accordance 
    with paragraph (d)(3) of this section.
        (3) Determination of responsible entity. If a failure to comply is 
    established under this section, the responsible entity, as determined 
    under this paragraph, is liable for the penalty. If the violation is 
    due to a failure by--
        (i) A health insurance issuer, the issuer is the responsible 
    entity;
        (ii) A group health plan that is a non-Federal governmental plan 
    sponsored by a single employer, the employer is the responsible entity;
        (iii) A group health plan that is a non-Federal governmental plan 
    sponsored by two or more employers, the plan is the responsible entity.
        (4) Notice to responsible entities. HCFA provides notice to the 
    appropriate entity or entities identified under paragraph (d)(3) of 
    this section that a complaint or other information has been received 
    alleging a violation of this part. The notice--
        (i) Describes the substance of any complaint or other allegation;
        (ii) Provides 30 days for the responsible entity or entities to 
    respond with additional information. This can include--
        (A) Information refuting that there has been a violation;
        (B) Evidence that the entity did not know, and exercising due 
    diligence could not have known, of the violation;
        (C) Evidence of a previous record of compliance.
        (5) Notice to other regulators. HCFA notifies the State if the 
    alleged violation involves a health insurance issuer under its 
    jurisdiction.
        (6) Notice of assessment. If, based on the information provided in 
    the complaint, as well as any information submitted by the entity or 
    any other parties, HCFA proposes to assess a civil money penalty, HCFA 
    sends written notice of assessment to the responsible entity or 
    entities by certified mail, return receipt requested. The notice 
    contains the following information:
        (i) A reference to the provision that was violated.
        (ii) The name or names of the individuals with respect to whom a 
    violation occurred, with relevant identification numbers.
        (iii) The facts that support the finding of a violation, and the 
    initial date of the violation.
        (iv) The amount of the proposed penalty as of the date of the 
    notice.
        (v) The basis for calculating the penalty, including consideration 
    of prior compliance.
        (vi) Instructions for responding to the notice, including--
        (A) A specific statement of the respondent's right to a hearing; 
    and
        (B) A statement that failure to request a hearing within 30 days 
    permits the imposition of the proposed penalty, without right of 
    appeal.
        (7) Amount of penalty--(i) Maximum daily penalty. The penalty 
    cannot exceed $100 for each day, for each responsible entity, for each 
    individual with respect to whom such a failure occurs.
        (ii) Standard for calculating daily penalty. In calculating the 
    amount of the penalty HCFA takes into account the responsible entity's 
    previous record of compliance and the gravity of the violation.
        (iii) Limitations on penalties. No civil money penalty is imposed:
        (A) With respect to a period during which a failure existed, but 
    none of the responsible entities knew, or exercising reasonable 
    diligence would have known, that the failure existed.
        (B) With respect to the period occurring immediately after the 
    period described in paragraph (d)(7)(iii)(A) of this section, if the 
    failure--
        (1) Was due to reasonable cause and was not due to willful neglect; 
    and
        (2) Was corrected within 30 days of the first day that any of the 
    entities against whom the penalty would be imposed knew, or exercising 
    reasonable diligence would have known, that the failure existed.
        (C) The burden is on the responsible entity or entities to 
    establish to the satisfaction of HCFA that none of the entities knew, 
    or exercising reasonable diligence could have known that the failure 
    existed.
        (8) Hearings--(i) Right to a hearing. Any entity against which a 
    penalty is assessed may request a hearing by HCFA. The request must be 
    in writing, and must be postmarked within 30 days after the date the 
    notice of assessment is issued.
        (ii) Failure to request a hearing. If no hearing is requested under 
    this paragraph, the notice of assessment constitutes a final order that 
    is not subject to appeal.
        (iii) Parties to the hearing. Parties to the hearing include any 
    responsible entities, as well as the party who filed the complaint. An 
    informational notice
    
    [[Page 16976]]
    
    is also sent to the State, or to the Secretaries of Labor and the 
    Treasury, as appropriate.
        (iv) Initial agency decision. The initial agency decision is made 
    by an administrative law judge. The decision is made on the record 
    according to section 554 of title 5, United States Code. The decision 
    becomes a final, appealable order after 30 days, unless it is modified 
    in accordance with paragraph (d)(8)(v) of this section.
        (v) Review by HCFA. HCFA may modify or vacate the initial agency 
    decision. Notice of intent to modify or vacate the decision is issued 
    to the parties within 30 days after the date of the decision of the 
    administrative law judge.
        (9) Judicial review--(i) Filing of action for review. Any entity 
    against whom a final order imposing a civil money penalty is entered in 
    accordance with paragraph (d)(8) of this section may obtain review in 
    the United States District Court for any district in which the entity 
    is located or the United States District Court for the District of 
    Columbia by--
        (A) Filing a notice of appeal in that court within 30 days from the 
    date of a final order; and
        (B) Simultaneously sending a copy of the notice of appeal by 
    registered mail to HCFA.
        (ii) Certification of administrative record. HCFA will promptly 
    certify and file with the court the record upon which the penalty was 
    imposed.
        (iii) Standard of review. The findings of HCFA may not be set aside 
    unless they are found to be unsupported by substantial evidence, as 
    provided by Section 706(2) (E) of title 5, United States Code.
        (iv) Appeal. Any final decision, order or judgement of the district 
    court concerning the Administrator's review is subject to appeal as 
    provided in Chapter 83 of Title 28, United States Code.
        (10) Failure to pay assessment, maintenance of action--(i) Failure 
    to pay assessment. If any entity fails to pay an assessment after it 
    becomes a final order under paragraphs (d)(7)(i)(A) or (d)(7)(iii) of 
    this section, or after the court has entered final judgment in favor of 
    HCFA, HCFA refers the matter to the Attorney General, who brings an 
    action in the appropriate United States district court to recover the 
    amount assessed.
        (ii) Final order not subject to review. In an action brought under 
    paragraph (d)(10)(i) of this section, the validity and appropriateness 
    of the final order described in paragraphs (d)(7)(i)(A) or (d)(7)(iii) 
    of this section is not subject to review.
        (11) Use of penalty funds. (i) Any funds collected under this 
    section will be paid to HCFA or other office imposing the penalty.
        (ii) The funds will be available without appropriation and until 
    expended.
        (iii) The funds may only be used for the purpose of enforcing the 
    provisions with respect to which the penalty was imposed.
    
    PARTS 147--199 [RESERVED]
    
        Authority: Secs. 2701 through 2723, 2791, and 2792 of the PHS 
    Act, 42 U.S.C. 300gg-41 through 300gg-63, 300gg-91, and 300gg-92.
    
        Dated: March 25, 1997.
    Bruce C. Vladeck,
    Administrator, Health Care Financing Administration.
    
        Dated: March 25, 1997.
    Donna E. Shalala,
    Secretary.
    [FR Doc. 97-8275 Filed 4-1-97; 12:42 pm]
    BILLING CODE 4120-01-M; 4830-01-M; 4510-29-M
    
    
    

Document Information

Published:
04/08/1997
Department:
Health Care Finance Administration
Entry Type:
Rule
Action:
Interim rules with request for comments.
Document Number:
97-8275
Pages:
16894-16976 (83 pages)
Docket Numbers:
T.D. 8716
RINs:
0938-AI08: Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F), 1210-AA54: Regulations Implementing the Health Care Access, Portability, and Renewability Provisions of the Health Insurance Portability and Accountability Act of 1996, 1545-AV05
RIN Links:
https://www.federalregister.gov/regulations/0938-AI08/portability-and-nondiscrimination-in-the-group-health-insurance-market-hcfa-2890-f-, https://www.federalregister.gov/regulations/1210-AA54/regulations-implementing-the-health-care-access-portability-and-renewability-provisions-of-the-healt
PDF File:
97-8275.pdf
CFR: (68)
29 CFR 2590.701-5(a)(2)
29 CFR 2590.701-4(a)
29 CFR 146.115(a)(2)
29 CFR 146.115(a)(4)(i)
29 CFR 146.111(a)(1)(i)
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